Job Description
Job Title: Validation Specialist - Pharma
Location: Vacaville, CA (Onsite)
Duration: 12 Months contract
Summary:
We are seeking an experienced Validation Specialist IV / Engineer IV to support qualification and validation activities at a large-scale pharmaceutical manufacturing facility in Vacaville, CA. This individual will lead validation strategy and execution across equipment, utilities, facilities, and cleaning validation programs, with a strong focus on hands-on validation in GMP manufacturing environments.
Key Responsibilities:
- Define validation and qualification strategies supporting manufacturing operations and project execution
- Lead execution of Equipment, Utility, and Facility Qualifications (IQ/OQ/PQ)
- Perform and support Cleaning Validation activities including protocol development, execution, and summary reporting
- Support CIP / SIP / Sanitization / Sterilization Validation programs
- Coordinate validation testing with Engineering, Manufacturing, and Quality teams
- Author, review, and execute validation protocols, reports, discrepancy investigations, and change controls
- Ensure compliance with cGMP, FDA, and industry regulatory requirements
- Defend validation rationale, risk assessments, and scientific approaches during audits/reviews
- Drive continuous improvement of validation processes and documentation standards
Required Qualifications:
- 7+ years of validation experience in pharmaceutical, biotech, or life sciences manufacturing
- Strong hands-on experience with Equipment Validation across full validation lifecycle
- Demonstrated expertise in Cleaning Validation
- Solid understanding of cGMP, FDA, and validation regulatory standards
Preferred Qualifications:
- Experience in large-scale commercial manufacturing facilities
- Experience supporting cross-functional project teams
- Ability to work independently and manage multiple validation activities simultaneously