Senior GMP QA Validation Specialist

Bayer; Berkeley (CA); On-site; USD 118,000 - 177,000; Full time

Job summary

Bayer in Berkeley, CA is seeking a QA Validation Specialist to provide QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and systems. You will apply 21 CFR Part 11 and ICH guidelines, review documentation, and lead cross-functional teams to ensure compliant quality across projects.

The ideal candidate has 5+ years in GMP-regulated settings, strong analytical skills, and experience with MES/LIMS/SAP and data integrity.

Qualifications

• 5+ years in GMP-regulated pharmaceutical operations with validation focus.
• Experience reviewing validation protocols and regulatory documents.
• Knowledge of FDA 21 CFR Part 11 and ICH guidelines.
• Experience with validation lifecycle activities for manufacturing processes, facilities, utilities, equipment, and computerized systems.

Responsibilities

• Provide 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.
• Review and approve qualification and validation documentation for systems and processes, including URS, risk assessments, 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, or improvement opportunities in procedures and practices; lead discussions and drive remediation activities.
• 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 GMP quality systems knowledge to assess critical issues and represent the site validation program during audits.
• Provide project team leadership by planning and facilitating team activities, supervising contractors, and cross-functional collaboration.

Skills

Quality assurance

Validation

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Attention to detail

Excellent communication

Education

Bachelor’s degree in a scientific or technical discipline

Tools

MES systems

LIMS

DCS/PLC/SCADA

Data historians

SAP ERP

Job description

Bayer in Berkeley, CA is seeking a QA Validation Specialist to provide QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and systems. You will apply 21 CFR Part 11 and ICH guidelines, review documentation, and lead cross-functional teams to ensure compliant quality across projects.

The ideal candidate has 5+ years in GMP-regulated settings, strong analytical skills, and experience with MES/LIMS/SAP and data integrity.