QA Validation specialist - Berkeley, CA

Bayer•Berkeley, CA

6d•$117,760 - $176,640•Onsite

About The Position

The QA Validation Specialist provides specialized quality assurance and control knowledge and technical support in a GMP-regulated environment. The role analyzes quality and validation data, develops best practices, advises cross-functional teams on compliance with industry standards and regulations, and collaborates with Manufacturing, Engineering, IT, and Quality to implement improvement initiatives, conduct training, and ensure products and processes meet quality and compliance benchmarks. The specialist provides manufacturing QA oversight and subject-matter expertise for validation and qualification of processes, facilities, utilities, equipment, and technical systems. The role maintains and improves the site validation program and its procedures, reviews and approves validation documentation, supports investigations and change assessments, leads remediation activities, and represents the site validation program during audits. It also provides project-team leadership, coordinates contractors as needed, and develops approaches 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.
Typically 5 or more years of hands-on experience in GMP-regulated pharmaceutical, biotech, or medical device operations focused on validation and quality assurance.
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, including FDA 21 CFR Part 11 and Parts 210/211, ICH guidelines, data integrity principles, and industry standards such as GAMP 5.
Demonstrated experience reviewing, authoring, and approving validation protocols, reports, SOPs, risk assessments, and traceability matrices, with strong attention to detail and compliance.
Solid understanding of QA systems, including change control, deviation and discrepancy management, CAPA, and audit and inspection readiness as they relate to validation activities.
Strong analytical and critical-thinking skills, including the ability to evaluate complex problems and make timely decisions that balance quality, compliance, and business needs.
Excellent interpersonal and communication skills and the ability to influence and collaborate across Manufacturing, Engineering, QA, IT, and project teams in a diverse, multidisciplinary environment.

Nice To Haves

Advanced degree in a relevant scientific or engineering discipline, such as an MS or PhD.
8–10 or more years of experience in validation, quality assurance, or computerized system validation roles within large-scale pharmaceutical or biotech manufacturing environments.
Experience serving as a site or program validation lead for major initiatives such as 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.
Practical experience with MES, LIMS, process control systems (DCS/PLC/SCADA), data historians, and ERP platforms such as SAP, particularly in validation and data integrity.
Experience presenting validation strategies and outcomes during regulatory inspections or corporate audits.

Responsibilities

Provide manufacturing support and QA oversight as a subject-matter expert for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems.
Serve as a subject-matter expert on validation lifecycle requirements, 21 CFR Part 11, ICH guidelines, and risk-based qualification approaches, maintaining alignment with current regulations and industry trends.
Review and approve qualification and validation documentation, 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.
Identify compliance issues, conflicting requirements, inefficiencies, and improvement opportunities; lead discussions and drive remediation activities to completion.
Provide QA oversight of technical-system and operations SOPs, approve SOPs, and influence internal partners on compliant processes, best practices, and high-quality documentation.
Resolve and approve validation discrepancies, participate in investigations related to validation failures, and assess technical-system changes for validation and quality impact.
Use GMP quality-system knowledge to assess critical issues and validation impacts on product quality and quality-system elements, and represent the site validation program and strategy during internal and external audits.
Lead project-team activities, supervise contractors as needed, and partner cross-functionally to define effective approaches for validation-related work.
Independently address complex-scope problems, select appropriate methods and techniques, and propose strategies to streamline computerized system validation and related processes.
Conduct training sessions and develop and deliver training on validation principles, SOPs, and best practices to cross-functional teams.