Job Description
Role: Validation Specialist IV (Engineer IV)
Location: Vacaville, CA (Onsite – 5 days/week)
Position Summary
We are seeking an experienced Validation Specialist IV (Engineer IV) to support validation activities in a regulated pharmaceutical manufacturing environment. This role is responsible for developing, executing, and documenting validation strategies across equipment, utilities, and facility systems in compliance with GMP requirements.
The ideal candidate will have strong hands-on experience in equipment qualification (IQ/OQ/PQ) and cleaning validation, along with the ability to clearly communicate validation strategies in cross-functional and audit settings.
Key Responsibilities
- Develop and execute validation and qualification strategies supporting manufacturing operations
- Lead Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
- Author, review, and execute validation protocols and summary reports
- Perform and support cleaning validation activities, including protocol development, execution, and reporting
- Support validation of equipment, utilities, facility systems, and related processes (e.g., CIP/SIP, sterilization)
- Coordinate validation activities with Engineering, Quality, Manufacturing, and other cross-functional teams
- Prepare and manage validation documentation including protocols, deviations, investigations, and change controls
- Ensure compliance with cGMP, FDA regulations, and applicable industry standards
- Provide clear technical justification for validation approaches during audits and reviews
- Support continuous improvement initiatives within validation systems and documentation practices
Required Qualifications
- 7+ years of validation experience in a regulated pharmaceutical, biotechnology, or life sciences manufacturing environment
- Strong hands-on experience with equipment qualification (IQ/OQ/PQ)
- Demonstrated experience in cleaning validation (protocol development, execution, reporting)
- Strong knowledge of cGMP and FDA regulatory requirements
- Experience writing and reviewing validation documentation (protocols, reports, deviations, change controls)
- Strong technical writing and communication skills
- Ability to work onsite 5 days per week in Vacaville, CA
Preferred Qualifications
- Experience in large-scale commercial manufacturing environments
- Exposure to sterile manufacturing processes and utility systems validation
- Strong collaboration and stakeholder management skills
- Ability to manage multiple validation activities in a fast-paced environment