Responsible for providing process engineering capabilities and experience. Incumbent’s efforts may focus on the design, implementation and/or start-up of a new and/or existing facilities with respect to process and/or clean utility systems. Responsibilities may include procurement activities, fabrication, factory acceptance testing, site installation, site acceptance testing, start-up and validation. Knowledge and experience working under GMPs and validation requirements is essential.
Review and provide recommendations on design drawings, which may include PFDs that incorporate mass balances and P&IDs, which include all line sizing, instrumentation and control philosophies.
Supervise external consulting engineers and provide process overview and review drawings and documents produced by these groups.
Interact with vendors concerning contracts of critical financial value and select vendors based on the most appropriate combination of price, quality and delivery. This often involves negotiations of a complex and/or controversial nature. Review and approve vendor information packages, including drawings and specifications. Make recommendations to senior staff.
Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning, problem solving, etc, in alignment with corporate objectives.
Play a key leadership role in the start-up and troubleshooting of process equipment and complex critical clean utility systems. Direct supporting engineering and manufacturing staff.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.
Provide key input into the validation of process equipment and associated utilities. Direct manufacturing and operations staff in the execution of validation protocols.
Provide technical support to manufacturing.
Provide technical assessments for investigations, validation and change control.
Manage corrective actions as a result of investigations.
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 the 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 one’s functional area. Fosters a positive safety culture in which no one gets hurt.
Perform equipment and system studies, research/evaluate process equipment components, review/modify equipment operation as a result of troubleshooting.
Act as a team leader to coordinate activities within the division and provide engineering leadership.
Present data and concepts at department, project team and other meetings within company and at outside conferences.
May provide direction to sub-contracting groups in the design and installation of process and clean utility systems. Oversee design specification testing and perform field inspection services.
May perform process design services for facility projects, upgrades and capacity expansions, equipment upgrading and replacement.
May exercise working or direct supervision.
May propose ideas for new programs in alignment with strategic planning.
Education and Experience
Bachelor’s degree in Engineering (Chemical preferred) and 8 years applicable equipment, clean utility and process system experience, or Master’s degree and typically a minimum of 6 years applicable equipment, clean utility and process system experience.
8 year applicable instrument and control system experience.
5 year in the pharmaceutical/biotech industry/GMP experience.
Knowledge, Skills and Abilities
Experience from a background of manufacturing, design or construction.
Good understanding of clean room or classified area design/requirements.
Working knowledge of computer systems or Windows applications for accessing control system software packages.
Strong working knowledge of Microsoft based programs.
Some experience with AutoCAD.
Thorough knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
Thorough knowledge of biopharmaceutical process operation and process control.
Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
Thorough knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.
Ability to generate engineering drawings and specifications.
Excellent organization and time utilization skills.
Excellent communication skills, both written and verbal.
Use creativity and innovation to address urgent and/or complex problems and propose solutions.
Requires use of wide variety of technical skills to solve multiple disciplinary complex engineering challenges. Will encounter diverse or difficult characteristics in engineering principles and concepts.
Work Environment/Physical Demands/Safety Considerations
Work in standard office environment.
May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
This position is not eligible for relocation.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.