Reporting directly to the Downstream Frontline Manager for CCP2 the Senior Manufacturing Engineer is responsible for the following:
Serve as a technical subject matter expert for all downstream processes (CIP, SIP, Buffer Preparation, Buffer Hold, Column Packing, Chromatography, Viral Filtration, Ultrafiltration/Diafiltration, Formulation, Drug Substance Dispensing, Cryovessel Freezing) to support make, assess, and release of GMP products.
Perform process monitoring of downstream unit operations to ensure process is performing as expected.
Perform troubleshooting of downstream unit operations when operational issues are encountered.
Evaluate unit operations (equipment design, automation configuration, procedural processes, user requirement specifications, functional specifications, Process Flow Diagrams, P&ID's, etc.) to determine opportunities to improve safety, quality, compliance, yield, efficiency, and reliability.
Participate in all aspects (owner, assessor) of change management processes to drive continuous improvement in the operation.
Interact with Quality, Regulatory and other functions and perform necessary process assessments, product impact assessments, and CAPA activities to support the closure of discrepant events including Quality investigations.
Establish strategies and associated documentation to perform equipment, and process commissioning activitives for downstream unit operations.
Participate in the generation, review, approval, and implementation of downstream manufacturing formulae (Automated recipes, worksheets, tickets, etc.) as well as SOPs, protocols, summaries, and other required processing documentation.
Serve as technical subject matter expert during health authority inspections.
Lead projects of high complexity in support of site goals.
Who You Are
BS or MS degree in Engineering (Chemical, Mechanical, Electrical).
Licensed Professional Engineer (strongly preferred).
Minimum 12 years work experience in cGMP biopharmaceutical production.
Thorough understanding of Good Manufacturing Practices (GMP’s) as they apply to bioprocess manufacturing
Possesses subject matter expertise of multiple downstream processing operations
Possesses experience working within highly automated unit operations.
Knowledge of GMP documentation principles and change control theory.
Understanding of the main business systems including LIMS, BHDS, DMS and POMS.
Ability to work with a cross-functional teams including MSATS, Facilities, Engineering, QA, QC, Validation, Automation.
Successful demonstration of technical expertise, mechanical aptitude, problem solving, training ability, communication, and initiative.
Ability to provide on-call (off-shift) support for timely, technical guidance to enable business objectives.
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.