QA Validation Specialist – GMP/CSV Focus

USA - 3390 Baxalta U.S., Inc.; Thousand Oaks (CA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda is seeking a Quality Assurance Validation Associate in Thousand Oaks to oversee validation deliverables and change controls, ensuring GMP and GxP compliance across facilities, utilities, equipment, and computerized systems.

The role emphasizes risk assessment, traceability, and collaboration with cross-functional teams to support regulatory submissions and manufacturing readiness.

Qualifications

• Bachelor’s degree in Biotechnology, Microbiology, Pharmacy or equivalent is strongly preferred.
• Minimum of 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.

Responsibilities

• Review validation documents against SOPs for accuracy and compliance with procedures and regulatory requirements.
• Assess validation documentation for proper project development and regulatory submissions.
• Review VMPs, DQ, IQ, OQ, PQ, CSV, and Validation Maintenance packages per procedures.
• Ensure deliverables comply with requirements and approve decommissioning documentation.
• Provide validation expertise for development or modification of facilities, utilities, systems, and computerized systems; address QA requirements.
• Participate in risk assessment and ensure traceability throughout the project life cycle.
• Support quality-related issues, assess and approve change controls, CAPAs and deviations; ensure regulatory conformance.
• Participate in internal/external audits and maintain project metrics.

Skills

Validation experience

US GMP knowledge

EDM systems

Cross-functional teamwork

Biotech/Pharma degree

Validation writing

Education

Bachelor’s degree in Biotechnology, Microbiology, Pharmacy or equivalent

Tools

Veeva

Kneat

ALM

Job description

Takeda is seeking a Quality Assurance Validation Associate in Thousand Oaks to oversee validation deliverables and change controls, ensuring GMP and GxP compliance across facilities, utilities, equipment, and computerized systems.

The role emphasizes risk assessment, traceability, and collaboration with cross-functional teams to support regulatory submissions and manufacturing readiness.