Senior QA Validation Engineer — GMP Compliance Leader

VTI Life Sciences; Thousand Oaks (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

VTI Life Sciences in Thousand Oaks, CA is seeking an experienced Quality Assurance Validation Specialist to provide oversight for pharma and biopharma validation activities. This on-site role collaborates across projects to ensure facilities, equipment, and processes meet regulatory standards and company procedures.

Responsibilities include reviewing validation documents, overseeing lifecycle activities (DQ/IQ/OQ/PQ/CSV), maintaining data integrity, and ensuring traceability from design through

Qualifications

• Bachelor’s degree in biotechnology, microbiology, pharmacy, engineering, life sciences, or related field.
• An advanced degree may be considered with relevant professional experience.
• Minimum six years in pharmaceutical/biotech regulated environments.
• Experience writing, reviewing, and executing validation protocols.
• Familiarity with GMP, data integrity, risk-based validation.

Responsibilities

• Review validation documents against SOPs and regulatory requirements.
• Assess documentation for accuracy, completeness, GMP compliance.
• Provide QA review and approval of validation deliverables.
• Review lifecycle deliverables: MDPs, DQ, IQ, OQ, PQ, CSV.
• Support validation across facilities, utilities, equipment, processes.
• Maintain traceability of requirements through project lifecycle.
• Collaborate with engineering, manufacturing, QA, validation, IT.

Skills

GMP compliance

Data integrity

Validation lifecycle

Technical writing

Education

Biotechnology degree

Microbiology degree

Pharmacy degree

Engineering degree

Life Sciences degree

Tools

Veeva

Kneat

ALM

Job description

VTI Life Sciences in Thousand Oaks, CA is seeking an experienced Quality Assurance Validation Specialist to provide oversight for pharma and biopharma validation activities. This on-site role collaborates across projects to ensure facilities, equipment, and processes meet regulatory standards and company procedures.

Responsibilities include reviewing validation documents, overseeing lifecycle activities (DQ/IQ/OQ/PQ/CSV), maintaining data integrity, and ensuring traceability from design through