Pharma QA Validation Engineer - Onsite, GxP Compliance

The Fountain Group

Thousand Oaks (CA)

On-site

USD 91,000 - 109,000

Full time

14 days+

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Job summary

The Fountain Group is seeking a QA Validation Specialist for a 6-month contract onsite in Newbury Park, Thousand Oaks, CA. You will lead cross-functional reviews of validation deliverables, ensuring compliance with SOPs, regulatory expectations, and data integrity across facilities, utilities, equipment, and computerized systems.

Ideal candidates have 5+ years in pharma/biopharma validation, strong IQ/OQ/PQ/CSV experience, and proficiency with Veeva, Kneat, and ALM.

Qualifications

Bachelor's degree in biotech/related field.
5+ years in pharma/biopharma manufacturing.
Experience with IQ/OQ/PQ/CSV and validation.
Experience writing and executing validation protocols.
Proficient in electronic document management systems (Veeva, Kneat, ALM).

Responsibilities

Review validation documents for accuracy and compliance with SOPs and regulatory requirements.
Review validation packages to support project development and regulatory submissions.
Approve documents related to system validation and decommissioning.
Provide QA support for facility, utilities, systems, processes and computerized systems.
Contribute to risk assessments and ensure traceability across the project life cycle.
Support GMP compliance and communicate risk trends to project timelines.