As a Principal Manufacturing Compliance Engineer, you will be at the forefront of developing and enhancing departmental capabilities to meet corporate needs, industry best practices, and regulatory expectations. You will coordinate and resolve issues across Biochemical Manufacturing Operations and collaborate on projects, ensuring seamless integration and exceptional problem-solving.
Your role will involve maintaining our quality system records in strict compliance with regulatory requirements, utilizing your deep knowledge of current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). You will perform critical, technical, and operational reviews and approve documentation related to the design, validation, operation, and maintenance of our manufacturing processes, equipment, and facilities. This includes engineering changes, document revisions, discrepant event assessments, and validation summaries.
Working closely with MSAT, Compliance, and Quality Assurance teams, you will address and resolve quality issues efficiently. You will manage, lead, and implement operational excellence initiatives, tackling complex problems while maintaining high standards of safety, quality, regulatory compliance, and production. As a key member of GMP Services, you will be fully accountable for compliance with all relevant laws, regulations, and policies governing GNE activities.
The Opportunity
Manage and Troubleshoot: Address and resolve technical and compliance issues in collaboration with Quality, Technology, and Facilities & Engineering (F&E) teams. Solve complex problems impacting multiple functions by applying advanced theory, technical principles, and expert judgment.
Quality Improvement: Lead efforts to troubleshoot and enhance quality processes and systems. Foster effective interdepartmental and cross-functional partnerships at both site and network levels to implement improvements.
Regulatory and Documentation Expertise: Provide technical assessments for controlled document changes and change requests. Act as a subject matter expert (SME) during regulatory agency inspections and contribute strategically to site inspections.
Technical and Procedural Issue Resolution: Identify and address technical, procedural, and equipment issues that may compromise production and compliance. Collaborate with cross-functional groups to implement effective solutions.
Compliance and Safety: Ensure operations adhere to cGMP standards and maintain a safe manufacturing work environment in compliance with company and state regulations. Implement and follow through on corrective and preventative actions (CAPA) as per timelines.
Mentorship and Leadership: Mentor and lead teams to foster a culture of compliance and operational ownership. Serve as a discrepancy owner leader, execute tasks in compliance with GSP009 and cGMPs, and support departmental and site goals.
Root Cause Analysis and Documentation: Facilitate Root Cause Analysis sessions for complex issues and act as a technical SME supporting cause analysis and remediation planning. Review and approve production-related documents, including process validation protocols, variance reports, and engineering change requests, ensuring compliance and site cycle time goals.
Who you are
BS/BA in Life Sciences/Engineering preferred, and at least 5 years’ experience in the pharmaceutical, biopharmaceutical industry or a combination of education and experience.
Ability to make sound decisions about scheduling, allocation of resources and managing of priorities.
Technical Expertise and Experience: Possess direct experience with mammalian cell culture and/or purification of biopharmaceutical products. Demonstrate thorough knowledge of cGMPs and expertise as a DMS Owner, with proficiency in CAPA and Change Control. Familiarity with FDA, ICH, and European guidelines is essential.
Communication and Writing Skills: Exhibit strong oral and written communication skills. Experience in technical writing, including creating and revising Standard Operating Procedures (SOPs) and other technical reports, is desirable.
Decision-Making and Problem-Solving: Capable of making sound decisions with minimal supervision. Manage complex assignments that require independent action, a high degree of initiative, and prioritization to resolve problems and develop recommendations. Full proficiency with computer-based systems is necessary.
Work Environment / Physical Demands / Safety Considerations
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
May work with hazardous materials.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of California is $100,500-$186,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.