Job Description

Are you ready to dive into a thrilling career opportunity where you can make a tangible impact on people's lives? The Sr. Quality Engineer (QEV) will be joining a collaborative team, where innovation, quality, and compliance are at the core of everything we do. In this role, you will oversee and guide the validation processes for critical systems, ensuring compliance and driving continuous improvement across a wide range of projects. This is a unique opportunity to leverage your expertise in quality engineering and working cross-functionally to resolve complex challenges.

The Opportunity:

• Review and approve a variety of end to end (Introduction, Maintain, and Retire) Validation Project Plans, Protocols (IQs, OQs, IOQs, PQs), Summary Reports, validation strategies, and other lifecycle documents for equipment, facilities, utilities, cleaning validation, process validation, or computerized systems.
• Track Validation activities and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
• Oversee protocol execution, perform data review and manage deviation resolution.
• Oversight and management of contract resources including: onboarding, training, work prioritization, budgeting, and execution as necessary.
• Evaluate and audit the current validated status of equipment, facilities, utilities, cleaning processes, manufacturing processes, and computerized systems. Make suggestions for strategic improvements as well as ensure systems are operating in compliance and validated state.
• Perform role of subject matter expert and assess change control and discrepancy events for validated systems. Review validation lifecycle documents for compliance with CFRs, corporate policies (PQS), and site procedures (SOPs).
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

Who You Are:

Bachelor’s Degree in Engineering, Life Science field or equivalent with 8-11 years combined engineering/validation/quality assurance/project management experience in a federally regulated industry.

• Minimum of 4 years validation experience in the pharmaceutical/biotechnology industry.
• Minimum of 3 years hands-on experience with equipment / utility / cleaning / process data review and analysis in a batch manufacturing environment.
• Hands-on experience commissioning/validating GMP equipment/utilities/processes preferred.
• Sound knowledge and understanding of GMP guidelines and US/international regulations applicable to the pharmaceutical/biotechnology industry.
• Subject matter expertise in at least one (1) of the following areas: equipment/facilities/utilities qualification, cleaning validation, process validation, computerized systems validation.- Experience in performing and/or oversight of process validation activities including technical product transfer is a plus
• Ability to influence project team members, customers, Technology Validation, Manufacturing, Engineering, and MTS in order to successfully achieve compliance with Quality requirements.

Days worked: M-F Days

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $94,000 to $174,600. 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.