QA Validation specialist - Berkeley, CA

Bayer•Berkeley, CA

7d•$117,760 - $176,640•Onsite

About The Position

The QA Validation Specialist provides specialized knowledge and technical support in quality assurance and control processes. The role analyzes quality and validation data, develops best practices, and advises cross-functional teams on compliance with industry standards and regulations. Working with Manufacturing, Engineering, IT, and Quality, the specialist implements quality and validation improvement initiatives, conducts training, and ensures products and processes align with quality and compliance benchmarks in a GMP-regulated environment. The role provides manufacturing support and QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems. It maintains and improves the site validation program and its procedures, reviews and approves validation documentation and technical-system SOPs, and supports compliance investigations, remediation, and change assessments. The specialist also represents the validation program during audits, leads project-team activities, supervises 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 validation-status review.
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 high attention to detail and compliance.
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, including the ability to work on complex problems, evaluate multiple factors, and make timely decisions balancing quality, compliance, and business needs.
Excellent interpersonal and communication skills, with 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 in large-scale pharmaceutical or biotech manufacturing environments.
Experience as a site or program validation lead for 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.
Practical experience with technical systems such as MES, LIMS, process control systems (DCS/PLC/SCADA), data historians, and ERP platforms such as SAP, particularly regarding 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.

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 a subject matter expert on 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, 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 SOPs for technical systems and operations, approve SOPs, and influence internal partners on 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.
Use GMP quality-system knowledge to assess critical issues, understand 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 by planning and facilitating work, supervising contractors as needed, and partnering cross-functionally to define effective approaches to validation-related tasks.
Work independently on complex problems, exercise sound judgment in selecting methods and techniques, and propose strategies to streamline computerized system validation and related processes.