The Sr. Automation Manager leads a diverse group of specialized individual contributors and management staff. The Group Leader is responsible for planning, organizing, directing, and staffing a group within the Production Automation department, with particular focus on one of the following areas: SSF cell culture, purification, GMP utility operations, fill/finish, data systems, data tools or MES.
Lead an outstanding team of individual contributors and contractors
Opportunity to influence/shape SSFP Automation Manufacturing Computerized system road-map and expansion of innovative, flexible and cost effective systems across the site.
Opportunity to influence Extended Site Leadership forums (departmental and site)
Outstanding partnership with all of the PIT and PTx sites as part of the ALC and RPAR
Cross functional leadership opportunities through daily collaboration with Informatics, Operations, Facilities, Quality and Engineering Teams
Drive continuous improvement within function, site and network
Technology Work Standards and Principles- Execute day-to-day duties to deliver required business results by maintaining work standards and principles for acting ethically, with integrity, diversity, inclusion, safely, and in compliance when carrying out your responsibilities at Genentech:
Adhere to US Pharma Code of Conduct (COC), Genentech Policy on Bribery and Improper Advantages, and Maintain Time (Leave and Absence) time regulated policies and regulations for time off, sick time, etc.
Support a speak-up culture by escalating and engaging on safety or quality related issues · Follow decision making framework
Maintain all core GMP and SHE training at target level of 100% on time, and before performing relevant work.
Adhere to safe working requirements at all times (promote and adhere to office ergo requirements and adhere to all safety requirements for standard and non-standard work).
Manage external contractors and consultants who are working for you to the above accountabilities, ensuring adherence to all of the above.
Adherence to Business Processes and Infrastructure- Comply with, maintain training on, innovate and champion established business processes (including robust onboarding) and infrastructure to create value for the business. Business processes and infrastructure include, but not limited to:
GMP document review and approval processes
Technical change management processes·
Roche Procurement Policy and Purchasing Policy
Contingent workforce policy and guidelines
Attendance at department and staff meetings
Project and Standard Work- Manage projects and deliverables following GNE business processes and applying Engrained Quality principles to ensure right first time, on-time delivery and within budget to achieve results:
Ensure all Quality and Change Management (e.g. CR, DMS, CAPA) is performed on time, following GMP procedures and site business processes.
Support Health Authority and internal audits as needed.
Execute and/or lead projects following the EM project delivery process and funding approval requirements to deliver on-time and to meet business and customer needs.
Support manufacturing issues after hours as required by job function.
Personnel Management Effectively manage and develop workforce in order to deliver results:
Actively manage group workload and allocations.
Establish clear expectations for all staff. Enable strong performance by giving performance feedback throughout the year. Review compliance of each employee to job accountabilities throughout the year. Hold each employee accountable to role expectations.
Ensure each employee has a development plan. Routinely revisit and provide coaching and development as necessary to achieve development goals.
Provide timely recognition using appropriate mode.
For STARI incidents initiated by direct reports, perform initial investigation and action assignment to appropriately address risk within 72 hours of incident initiation.
Sponsors (CAPA, projects, tech transfers, etc.) actively engage with leads to remove roadblocks, gain alignment, and proactively escalate resource constraints/barriers impeding meeting deliverables.
Balance short-term needs with long-term strategic goals (e.g. technical leadership, reliability, agility, etc.) for the organization.
Develop group vision, objectives, and gain feedback from key stakeholders to support site strategies and goals.
Direct supervision of Biochemical Automation staff
Provide goals and objectives as needed for 2-6 people
Work with subordinates to develop the necessary skills needed to achieve objectives
Assist in the career development of subordinates
Review and approve validation protocols.
Review and approve qualification and change control documents.
Represent the Automation Engineering department on cross-functional teams.
Technical leadership of projects and Quality records (investigations, CAPAs, DMS, etc.).
24x7 support of manufacturing computerized systems.
Write and administer performance evaluations.
Recruit and interview job candidates for Automation Engineer positions.
Ensure that department members are following and adhering to accepted engineering standards
Effectively communicate to subordinates all cGMP regulations, policies, and SOP’s directly applicable to Automation Engineering.
Adhere to and enforce Genentech policies and procedures relating to Biochemical Automation.
Suggest quality improvement, efficiency improvement and cost reduction programs in order to insure that the most effective “best practices” are in place.
Training Duties- Aid in the training and development of Automation Engineers
Establishes new technical concepts, platforms and automation strategies (L2/L3 systems)
Project automation strategy: including technology selection, automation justification, level of automation, modularization & engineering re-use, and cost benefit analysis.
Has expertise in Automation life cycle management, Automation platform(s), regulatory and industry requirements and trends (ICH, CFR part 11, EM/FDA, PQS QR020, GSP97/48) to effectively
influence the site’s longer-term objectives and migration plans for the next generation of Automation platforms (Delta V, Rockwell, REMIS, Distillery, , )
Has responsibility of Sr. engineers other supervisory level individuals (E4 and S2)
Manages team working on diverse and complex problems and initiatives and makes independent decisions impacting the Automation department and PTG/Site (CAPEX projects 500K-10MM, and CAPEX>10MM as UTL, CTL, Discipline Lead/PM)
Effectively interacts with senior staff (1-2 levels) inside/outside (TLT, SPLT, Global Eng. LT, PIT) and represents SSFP and Roche Automation in industry/NW forums (ALC, REBAR, Vendor forums, GSC, PTA MES CoE)
Influences department budget and has budget management responsibility (HC decision input, Service contracts, contract review and approval, Capital project POs/WBS approval, T0/T3 planning participation)
Participate and influences the PTG department strategy development (TLT, Facility Footprint, etc.)
Approval authority as a delegate for Department head in most cases
Champions site initiatives (eSPLT and SPLT assignments)
Develops life cycle management requirements for all Mfg. software systems
Develops migration and replacement strategies for Mfg. software systems
Develops alliances with vendors and global Informatics for support of enterprise systems
Sustain global data audit process and ensure that it is followed
Forecast and adhere to departmental budget, and responsibly manage cost center resources
Continually improve customer service and satisfaction in PIT, PTD and SSFP
Review and analyze system performance to rapidly and effectively address incidents and issues
Ensure that employee safety (including office ergonomic safety) is maintained as a high priority
Represent the department with global groups and Business Process Owners
·10+ years of process automation/Mfg. experience, 1-3years direct/indirect supervisory, Global and multi-site responsibilities for DCS integration
·Significant capital project delivery experience including cost and business case development.
·Proficiency with validated change management, discrepancy management, inventory management, and production control systems with proven knowledge of cGMP compliance requirements and GAMP.
·Champions self-initiated or assigned projects. Justifies business case, drivers and project goals to colleagues and leadership.
·Understanding of organizational change management principles
·Skilled communicator and teacher; professional level facilitator and effective advocator
·Professional level written and oral communication skills
·Working experience with supporting multiple controller platforms (such as Allen-Bradley PLC 5 & ControlLogix, Foxboro I/A, Siemens, Invensys, DeltaV etc.) and interfaces (GE iFix, RSView, etc.), Theoretical and applied knowledge of process instrumentation, classical process control, continuous process control, Electrical areas and S88 Batch programming, validation and GMP regulations applicable to automated systems (including ISPE GAMP guidelines), ISA standards and P&ID nomenclature, review of instrumentation and electrical wiring diagrams, communication networks, installation and troubleshooting.
Education & Training Requirements:
·B.S. or equivalent in computer science or engineering
·Expertise in Enterprise Resource Planning (ERP) and Manufacturing Execution System (MES) design, integration, performance and functionality.
·capital projects within the pharmaceutical industry and in partnership with vendors.
Work Environment/Physical Demands/Safety Considerations:
General office work including working on a computer terminal developing engineering documents and software.
Manufacturing support including working on processing equipment supporting Genentech’s South San Francisco manufacturing facility
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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