The Clinical Specialist, Franchise Sales manages anddevelops long-term relationships with physicians and other customers for thecustomer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) andtheir approved indications; helping external customers such as physicians,nurses, etc. learn about the benefits of the assigned GNE brand(s) in relationto the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularlyrequired 
...

Summary:

Team Overview:

The HTO Planning and Scheduling team partners with the business and other functional groups at HTO to deliver business results focused on exceeding customer expectations and optimization of the Schedule, Make, Assess and Release business processes; improving reliability and enabling exceptional operational performance.

Position Overview:

The Sr Planner Scheduler is responsible for managing the daily plant schedule for production and non-production activities to support budgeted production and site priorities at Genentech’s aseptic fill and finish facility in Hillsboro, OR.  He/She will also play a critical role in developing project timelines and achieving project milestones in support product transfer activities in drug product aseptic filling operations, product inspection and commercial packaging operations.   The successful candidate must effectively lead a daily team meeting to coordinate and prioritize plant activities within existing resources, effectively manage due dates, and proactively mitigate issues impacting operations.  This individual must also be able to assist in the development, implementation and continuous improvement of related business processes.   

...

The Clinical Specialist, Franchise Sales manages anddevelops long-term relationships with physicians and other customers for thecustomer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) andtheir approved indications; helping external customers such as physicians,nurses, etc. learn about the benefits of the assigned GNE brand(s) in relationto the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularly required 

...

HCV Sr. Clinical Coordinator
Territory: IL, MN, WI, ND, SD, and part of MI and KY. (Preferred location is Chicago; will consider Minneapolis) 

HCV Sr. Clinical Coordinators are responsible for the active promotion of Genentech's HCV product portfolio and focus their attention on key specialty customers and thought leaders. HCV Sr. Clinical Coordinators are expected to deliver on-label messages in support of product indications. HCV Sr. Clinical Coordinators implement programs and tools pertinent to the successful expansion of Genentech's HCV products in the treatment of HCV and other approved indications. The job requires an advanced level of technical and consultative selling skills. HCV Sr. Clinical Coordinators are preferably experienced working in a broad range of customer segments and in accordance with operational polices so as to appropriately influence current and future prescribers of Genentech products. The HCV Sr. Clinical Coordinator function is in a dual capacity through independent efforts and as a team player with the field and headquarters-based staff to ensure sound business strategies and services are being implemented. The HCV Sr. Clinical Coordinator must comply with all sales force promotional guidelines. 
...

Position Overview/Job Responsibilities

Genentech Government Affairs’ Public Policy and Reimbursement team is seeking a qualified policy manager/senior policy manager candidate to monitor and analyze numerous public payer activities and trends, including coverage, coding, and payment policies at the national level for both Medicare and Medicaid.

Specifically, the policy manager/senior policy manager will help recognize, assess, and communicate key policy issues that may impact Genentech and the biotechnology industry in both the short- and long-term to key internal and external stakeholders. He or she will focus on the impact of public sector trends and initiatives on Genentech with respect to patient access, reimbursement, and customer satisfaction. He or she will translate policy developments into meaningful guidance and strategic advice and will represent the Public Policy team at internal and external meetings. He or she also will be responsible for managing projects effectively and efficiently, and will be required to take initiative to identify key issues and help organize and assist the efforts of other team members as appropriate.

...

Utilities Frontline group is looking for candidates in 2013 that wants real-world learning opportunity in the Pharmaceutical/Biotechnology Industry. The candidate’s responsibilities include assisting Utility Frontline (UFL) Automation Engineer in
 
1) Lean Six Sigma and other continuous improvement projects
2) Implementation plan and test protocol generations
3) Change implementation
4) Programming of PLC and HMI

Candidates should be comfortable with some repetitive administrative task. Candidate should also be able to follow appropriate SOPs and other written procedures and document all work with great attention to detail.  In return, candidate will acquire hands-on skills and knowledge of Automation, and Industrial Control Engineering used in the Pharmaceutical/Biotechnology Industry.

Job Responsibilities:

• Provide assistance to the AE with data collection for Lean Six Sigma project
• Provide assistance to the AE with the various duties on a day-to-day basis
• Provide administrative assistance to AE such as test protocol generation and change implementation documents development.
• Develop an understanding of Automation system and utilize the acquired skills to projects assigned.

...

Provide automation support for biopharmaceutical manufacturing operations as part of the Vacaville Technology Upstream Frontline Group. Support will primarily be focused on the manufacturing production Distribution Control Systems (DCS) system involving cell culture manufacturing including fermentation, media prep, and harvest operations. Candidate must be a self-starter who can independently drive day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member in an informal results oriented environment.

Responsibilities: Automation design and support to the manufacturing Distributed Control System (Siemens APACS, APS, Archestra) as well as providing support to implement automation changes. This person is expected to perform troubleshooting of process, equipment, and system malfunctions or failures involving the DCS system, including after-hours on-call support on a rotational basis. Ability to initiate corrective or preventative actions to ensure continued compliant operation including emergency change records as needed. Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as provide technical input for investigation and/or developing and implementing corrective action plans. A key part of this person’s role will be to redline automation functional specifications for automation lead review/approval, troubleshoot the DCS system and software, prepare automation software change work plans and perform off-line and on-line coding and testing. This person will support automation projects with activities such as detailed design, design review, implementation, testing/debug, and troubleshooting. This position includes working with the Manufacturing, BSI, Quality, Facilities, and Technology departments to implement software changes. This person will be expected to clearly communicate across functional departments at various levels to drive efficient issue resolution and change implementation. The position may involve the cross-training in another discipline within Upstream Frontline, such as Validation, Process Engineering, or Manufacturing Sciences where business needs allow.

...

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

...

Create and edit controlled documents at all levels of complexity consistent with current formats and department style guides using the DocLink Electronic Document Management System (EDMS). Ensures document changes have been approved within the Trackwise Technical Change Management System.  Ensure new, revised, retried, or temporary documents are in accordance with Quality Requirements and Global Standard & Processes. Ensure requirements for making document changes are met. Verify the changes being made to the document have been authorized in the change record.  Initiate a document change workflow to execute a document change. Edit the document according to the change record.  Perform final review of the document for consistency and completeness.  Assign the appropriate document approvers. Collaborate with the Change Owner and Change Controller to resolve issues when a document is rejected. Ensure all document approval signatures have been obtained prior to releasing the document. Ensure all gating, training, and change deployment requirements outlined in the change record are considered when releasing the document and assign an effective date for the document. Maintain a master copy of all controlled documents released locally in a secure location.  Support the Controlled Document Manuals (CDMs) and the Document Audit Reporting program.  Evaluate and prioritize assigned document workload to meet internal productivity targets.  Partner with other change control groups to coordinate changes with cross site impact. Represent department on interdepartmental project teams. Track and communicate the status of document changes and projects. Enforce document and change control policies and procedures. Participate in document change control process improvement initiatives.  Train new hires and internal customers, as appropriate.  Support generating and presenting data for agency and third party audits.

Follow company policies and procedures. Maintain a state of inspection readiness.

Provide input to the development of personal performance goals and departmental objectives.

Collaborate with Management to establish and meet targets and timelines. Independently manage competing priorities with limited instruction. Serve as a Quality representative on cross-functional and multi-site teams. Identify and recommend solutions to potential procedure, process and system gaps. Provide assistance to customers in support of departmental functions. Participate in the design and implementation of department and cross-functional initiatives. Apply basic theory and technical principles to address moderately complex problems.

Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Serve as a technical subject matter expert (SME) in support of department functions. Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities.

...

Main Purpose of the Position:

• Supervise and develop Environmental Quality Control and Microbiology (EQCM) staff that perform routine and moderately complex testing activities and follow cGMP regulations and Genentech standards.  

• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:

• Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.

• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.

• Assign activities to staff.

• Routinely monitor progress and completion of assigned staff activities.

• Supervise routine activities of moderate complexity.

• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

• Meets scheduled performance of 95% on time.

• Perform any other tasks as requested by Senior Management to support Quality activities.

Technical Duties/Responsibilities:

• Provide technical and compliance guidance on test methods.  

• Review, evaluate and approve test data against established criteria.

• Provide input for the resolution of Out of Specification (OOS), complaints, discrepancies and Corrective and Preventive Actions (CAPA).  Design testing strategy to support investigation.

• Review technical / investigation reports and provide input as requested.

• Identify potential improvements to Quality Control systems and procedures gaps, and implement improvements as directed.

• Provide guidance and coaching in the application of cGMP throughout Quality Control operations.

• Receive and provide training.

• Participate in collaborations to support complex and/or multi-site projects.

• Participate in internal and external audits and regulatory inspections.

• Provide input and guidance to authors of protocols and reports.

• Review and approve proposed changes to systems, test procedures, test methods, procedures and submissions to regulatory agencies.

• Participate in validation and qualification studies.

...

Job Responsibilities:

• Provide hands-on maintenance, repair, fault diagnosis and troubleshooting of industrial electrical systems, including, but not limited to: VFDs, Soft and across the line motor starters, UPSs, Switchgear, Emergency Generators, Transformers, control systems, Standard and Emergency Lighting systems, etc.

• Safe operation of tools and testing equipment, and safe execution of work in the field.

• Timely completion of tasks and work orders with appropriate documentation according to applicable standards.

• Identify, anticipate, organize, and initiate acquisition of spare parts, safety equipment, engineering documents, service manuals, and test equipment.

• Ability to read and understand Electrical Drawings.

• Basic computer skills, with the ability to utilize the corporate intranet and applications, CMMS, and standard word processing and spreadsheet programs.

• Develop preventive maintenance and operational procedures for industrial electrical systems and equipment throughout the facility.

• Prepare and organize technical documentation, including red-lining documents to match as-built conditions.

• Coordinate contractors performing maintenance, repairs, modifications, and installation of electrical equipment.

• Inspect new installations and modifications by contractors and effect necessary changes to comply with company and industry standards.

• Communicate appropriately, verbally and in writing, with Engineering and other Plant department’s to ensure satisfactory performance of electrical systems.

• Represent Utility Operations on multidisciplinary project teams.

...

• Provide project management and administrative support for project team working to determine feasibility of Leadership Energy and Environmental Design (LEED) Certification.

• Work with LEED consultant to set clear performance expectations for team members to ensure successful completion of project objectives.

• Communicates and coordinates among all stakeholders within and outside the GNE organization including but not limited to client groups, service providers, suppliers, procurement to collect LEED Certification data.

• Manage data collected to enable reporting required to generate reports for feasibility or certification processes.

• Organize and develop material for presentation to Genentech and members of the U. S. Green Building Council (USGBC) for LEED Certification.

• Demonstrated success in leadership and organizational management in a technical, team orientated environment.

• Demonstrated ability to anticipate, prioritize, and adapt to changing workload situations.

• Excellent interpersonal and communication skills.

...

Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

• Cell Culture Manufacturing (CCM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations.
• Purification Operations Group (POG): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems.
• Centralized Manufacturing Services (CMS): Provide support to Manufacturing and Quality Control to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials;  Provide quality materials and service to our customers.

Job Responsibilities:

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
  

...

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for downstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

 

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as downstream frontline representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in the following areas;

·        Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·        Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

...

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for upstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as USFL representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in two areas;

·         Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·         Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

...

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

 

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• Operate systems that clean and sterilize tanks and filtration systems. 

• Prepare solutions for the production process.

• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).

• Trouble shoot equipment and process problems.

• Comply with safety requirements, cGMP, SOP and manufacturing documentation.

• Use of automation to perform production operations.

• Provide support to Manufacturing to meet production demands.

• Operate automated systems for equipment operation.

• Assemble and prepare equipment for production.

• Exhibit detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Exhibit professional interpersonal skills.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.

• Operate and clean fixed tank and filtration systems.

• Operate large scale column chromatography systems.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

...

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

...

Responsible for implementing and maintaining the validated state of equipment, IQ,OQ,SIP and cleaning validation programs. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol
report closure for the site. Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

...

Essential
• Responsible for training staff members and employees in the areas of cGMP Training, technical skills, safety, Performance and Best Practices. Responsible for Training Logistics and the Strategic development of organization's technical capability .
• Manages internal technical and compliance issues.
• Manages internal review of all training programs, policies, and practices to ensure compliance
• Coaches the management team to develop and implement viable operational processes that are robust and scalable.
• Ensures training and performance improvement programs are effective and utilizes constrained resources efficiently.
• Prepares and is proactive in overseeing compliance internally to ensure compliance with FDA and EU regulations.
• Oversees GMP training records and inspection preparation efforts, represents training as a quality system to regulatory agencies.
• Remains current in industry and sector best practices and approaches.
• Provides input and oversight of the budget for TrainingiInstructional design programs and third party delivery of training programs.
• Assists in selecting and overseeing the work of training consultants, contractors, and vendors
• Promotes a safety culture that support continuous improvement in the EHS management system through active communication and functional area participation in site safety teams ensuring the safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt....