Under the direction of the Head of Engineering in South San Francisco Production, the Manager/Sr. Manager is responsible for managing a staff of engineers and contractors to support project management of Drug Substance, Drug Product, and Facility projects for the South San Francisco Production Business Unit. The Manager/Sr. Manager provides engineering discipline leadership and management in the South San Francisco Engineering Group, providing operational process engineering support for existing manufacturing operations with respect to process equipment, clean and plant utility systems. Focus is in multiple areas such as design, implementation and/or start-up of new and/or existing facilities. The Manager/Sr. Manager cultivates important strategic relationships with partner functions inside South San Francisco Production, and in Site Services, Corporate Engineering, and PT Development functions in order to influence site investment strategy and enable project execution success.
Responsible for hiring, coaching, developing and motivating a team of process engineers and project managers.
Oversee direct reports' procurement activities, fabrication, factory acceptance testing, site installation, site acceptance testing, start-up and validation.
For design, qualification and technical change management, ensure alignment with cGMP expectations and compliance with internal quality standards as described in the Production Quality System.
Represent South San Francisco Production on equipment design and qualification related topics in audits and Health Authority inspections.
Review and provide recommendations on design drawings, which may include PFDs that incorporate mass balances and P&IDs, line sizing, instrumentation and control philosophies.
Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning, and problem solving in alignment with corporate objectives.
Play a key leadership role in the start-up and troubleshooting of process equipment and clean utility systems.
Provide key input into the validation strategy of process equipment and associated utilities.
Act as a team leader to coordinate activities and provide engineering leadership for equipment and system studies, research/evaluate process equipment components, and review/modify equipment operation as a result of troubleshooting.
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.
Involved in strategic planning and providing alignment with new programs.
Contribute or lead the development of the department’s annual cost center budget; implement budget and review/maintain controls in alignment with approved functional and project cost center budgets
We are seeking qualified applicants who reside locally in the Bay Area. The level of the position will depend on the qualifications of the selected candidate.
Bachelor's degree or higher in an Engineering discipline (Chemical, Mechanical, Electrical).
8+ years engineering experience with a focus on design and installation of equipment and systems in the pharmaceutical/biotech industry/GMP for the Manager level; 12+ years required for the Sr. Manager level. Advanced degree may count toward years of experience requirements.
3+ years in a supervisory role for the Manager level; 5+ years for the Sr. Manager level.
Good understanding of clean room or classified area design/requirements.
Thorough knowledge of biopharmaceutical manufacturing, process controls, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
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, read, and interpret engineering drawings and specifications.
Excellent organization, delegation, and time management skills.
Excellent interpersonal skills with an ability to interact well with a variety of people, craft skills and educational levels. Excellent communication skills, both written and verbal.
Use creativity and innovation to address urgent and/or complex problems and propose solutions.
Comply with GMP requirements (gowning, documentation, procedures) for performing work within the manufacturing plant.
Continuous improvement mindset focused on systems and processes.
Work Environment/Physical Demands/Safety Considerations
May work in the clean room environment that requires gowning in the form of hospital scrubs, clean room gowns, gloves and steel toe boots.
May work in clean room environment or Utility spaces with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air. Hearing protection may be required.
May be exposed to hazardous materials and chemicals.
Only locally based applicants will be considered. No 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.
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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.