Responsible for providing process engineering capabilities and experience. Focus will be on one or more areas such as design, implementation and/or start-up of 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.
Interact with vendors concerning contracts of significant financial value and select vendors based on the most appropriate combination of price, quality and delivery. This involves occasional negotiations of a complex and/or controversial nature. Review and approve vendor information packages, including drawings and specifications. Make recommendations to senior staff.
Play a leadership role in the start-up and troubleshooting of process equipment and critical clean utility systems.
Develop, manage and integrate key aspects of significant projects such as budget, schedules, resource planning, problem solving, etc, in alignment with corporate objectives.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems.
Direct external consulting engineers and provide process overview. Review drawings and documents produced by these groups.
Perform factory inspections of vendor-supplied equipment to ensure that construction and performance meets specifications.
Provide key input into the validation of process equipment and associated utilities. Direct manufacturing and operations staff in the execution of validation protocols.
Propose ideas for new projects in alignment with strategic planning.
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.
Present data and concepts at department, project team and other meetings within company.
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 act as a team leader to coordinate activities within the division and provide engineering leadership.
Education and Experience
Bachelor’s degree in Engineering (Chemical preferred) and 4 years applicable equipment, clean utility and process system experience, or Master’s degree in Engineering (Chemical preferred).
Minimum 2 year applicable instrument and control system experience.
Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience.
Knowledge, Skills and Abilities
Experience in manufacturing, design or construction.
Understanding of clean room or classified area design/requirements.
Good working knowledge of computer based programs and systems.
Working knowledge of Windows applications for accessing control system software packages.
Experience with AutoCAD.
Knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
Knowledge of biopharmaceutical process operation and process control.
Knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
Knowledge of process controls to enhance troubleshooting abilities and for application to future designs.
Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
Knowledge of cGMP guidelines, experience in generation of controlled documents and some experience in equipment start-up and validation.
Ability to generate engineering drawings and specifications.
Good organization and time utilization skills.
Strong communication skills, both written and verbal.
Proven ability to 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.
Ability to work autonomously on assignments and projects.
Comply with GMP requirements (gowning, documentation, procedures) for performing work within the manufacturing plant.
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.
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 .