QA Validation specialist - Berkeley, CA

At Bayer, we believe work should matter. Every day, our teams push toward a future where 'Health for all, Hunger for none' is within reach, and every role, from the lab to the field to the boardroom, helps us get there.

As a QA Validation Specialist, you will provide specialized knowledge and technical support in quality assurance and control processes within the organization. You will analyze quality and validation data, develop best practices, and advise cross-functional teams on compliance with industry standards and regulations.

Your tasks and responsibilities:

• Provide manufacturing support as a subject matter expert, delivering QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems.
• Serve as subject matter expert for validation lifecycle requirements, 21 CFR Part 11, ICH guidelines, and risk-based qualification approaches, ensuring alignment with current regulations and industry trends.
• Review and approve qualification and validation documentation for systems and processes, including impact assessments, URS, risk assessments, traceability matrices, IQ, OQ, PQ, data migration activities, and related SOPs.
• Maintain and continuously improve the site validation program and associated procedures, including Validation Plans, Validation Master Plans, and Validation SOPs, to align local practices with corporate and regulatory expectations.
• Identify compliance issues, conflicting requirements, inefficiencies, or improvement opportunities in procedures and practices; lead discussions and drive remediation activities to completion.
• Provide QA oversight of SOPs for technical systems and operations, approve SOPs, and influence internal partners on best practices, compliant processes, and high-quality documentation.
• Resolve and approve validation discrepancies, participate in investigations related to validation failures, and assess changes to technical systems for validation and quality impact.
• Utilize in-depth knowledge of GMP quality systems to assess critical issues, understand validation impact on product quality and quality system elements, and represent the site validation program and strategy during internal and external audits.
• Provide project team leadership by planning and facilitating team activities, supervising contractors as needed, and partnering cross-functionally to define effective approaches to accomplishing validation-related tasks.
• Work independently on problems of complex scope, exercise sound judgment in selecting methods and techniques, and propose new strategies to streamline computerized system validation and related processes.

Requirements:

• Bachelor’s degree in a scientific or technical discipline such as Pharmacy, Chemistry, Biology, Engineering, or a related field.
• Several years of hands-on experience, typically 5+ years, in GMP-regulated pharmaceutical, biotech, or medical device operations with a focus on validation and quality assurance.
• Strong expertise in validation lifecycle activities for manufacturing processes, facilities, utilities, equipment, and computerized systems, including URS development, risk assessments, IQ/OQ/PQ execution, and periodic review of validation status.
• In-depth knowledge of relevant regulatory requirements and guidelines such as FDA 21 CFR Part 11 and Parts 210/211, ICH guidelines, data integrity principles, and industry standards including GAMP 5.
• Demonstrated experience reviewing, authoring, and approving validation protocols, reports, SOPs, risk assessments, and traceability matrices with high attention to detail and compliance.
• Solid understanding of QA systems including change control, deviation and discrepancy management, CAPA, and audit/inspection readiness as they relate to validation activities.
• Strong analytical and critical-thinking skills with the ability to work on complex problems, evaluate multiple factors, and make sound, timely decisions that balance quality, compliance, and business needs.
• Excellent interpersonal and communication skills, with the ability to influence and collaborate effectively across Manufacturing, Engineering, QA, IT, and project teams in a diverse, multidisciplinary environment.

Preferred qualifications:

• Advanced degree in a relevant scientific or engineering discipline such as an MS or PhD.
• 8–10+ years of experience in validation, quality assurance, or computerized system validation roles within large-scale pharmaceutical or biotech manufacturing environments.
• Experience acting as a site or program validation lead for major initiatives such as new facility start-ups, technology transfers, large system implementations, or significant process changes.
• Formal training or certifications in Computerized System Validation, Quality Assurance, Six Sigma, or Project Management.
• Deep practical experience with technical systems such as MES, LIMS, process control systems (DCS/PLC/SCADA), data historians, and ERP platforms like SAP, particularly in the context of validation and data integrity.
• Experience presenting validation strategies and outcomes during regulatory inspections or corporate audits, and developing and delivering training on validation principles, SOPs, and best practices to cross-functional teams.

Benefits:

• Salary between $117,760.00 - $176,640.00
• Additional compensation may include a bonus or commission (if relevant)
• Health care, vision, dental, retirement, PTO, sick leave, etc.