QA Validation Specialist — GMP & 21 CFR 11 Expert

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

Job summary

Bayer in Berkeley, CA seeks a QA Validation Specialist to provide QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems. You will collaborate with Manufacturing, Engineering, QA, IT, and project teams to implement validation improvements.

You will apply deep GMP knowledge, FDA 21 CFR Part 11, ICH guidelines, data integrity, and GAMP 5 to review and approve validation docs, lead lifecycle activities, and drive remediation

Qualifications

• Bachelor's degree in a scientific or technical discipline (e.g., Pharmacy, Chemistry, Biology, Engineering)
• 5+ years of hands-on GMP-regulated pharma/biotech/medical device validation and QA experience
• Experience with validation lifecycle activities for manufacturing processes, facilities, utilities, equipment and computerized systems
• Knowledge of FDA 21 CFR Part 11, ICH guidelines, data integrity principles, and GAMP 5
• Experience reviewing, authoring, and approving validation documents with attention to detail and compliance
• Understanding QA systems including change control, deviations, CAPA and audit readiness
• Strong communication skills to influence across Manufacturing, Engineering, QA, IT and project teams

Responsibilities

• Provide QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment and technical systems
• Lead validation lifecycle activities and ensure alignment with regulatory expectations
• Review and approve validation documentation (URS, IQ/OQ/PQ, risk assessments, traceability matrices)
• Maintain and improve site validation programs, plans, and SOPs
• Identify and drive remediation of compliance issues and process inefficiencies
• Oversee SOPs for technical systems and operations; influence best practices
• Support investigations related to validation failures and assess changes for impact
• Represent site validation strategy during audits and regulatory inspections
• Provide project leadership, supervise contractors, and collaborate cross-functionally

Skills

Validation lifecycle

URS development

Risk assessments

IQ/OQ/PQ execution

Data integrity

GAMP 5

Computerized System Validation

Six Sigma

Project Management

SAP ERP

MES/LIMS

Education

Bachelor's degree in a scientific or technical discipline

Tools

MES

LIMS

DCS/PLC/SCADA

ERP (SAP)

Job description

Bayer in Berkeley, CA seeks a QA Validation Specialist to provide QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems. You will collaborate with Manufacturing, Engineering, QA, IT, and project teams to implement validation improvements.

You will apply deep GMP knowledge, FDA 21 CFR Part 11, ICH guidelines, data integrity, and GAMP 5 to review and approve validation docs, lead lifecycle activities, and drive remediation