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. We give people the ownership to shape outcomes, the support to grow through new skills and experiences, and a global community where different perspectives are valued.

If you want your work to count and the room to become your best, you'll find it here.

QA Validation specialist - Berkeley, CA Provides specialized knowledge and technical support in quality assurance and control processes within the organization; as a QA Validation Specialist, you analyze quality and validation data, develop best practices, and advise cross-functional teams on compliance with industry standards and regulations; you collaborate with Manufacturing, Engineering, IT, and Quality to implement quality and validation improvement initiatives, conduct training sessions, and ensure that all products and processes align with established quality and compliance benchmarks within a GMP-regulated environment.

YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, QA Validation Specialist, are to:

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.

WHO YOU AREBayer seeks an incumbent who possesses the following:

Required Qualifications:

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…