Program specialist • vacaville ca
Job Title:</b> Validation Specialist<br data-end="162" data-start="159" /> <b>Location:</b> Vacaville, CA<br data-end="216" data-start=&quo... Show more
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Job Title: Validation Specialist
Location: Vacaville, CA
Duration: 12 Months
Job Description:
Key Responsibilities
Develop and execute qualification and validation strategies to support manufacturing operations and process improvements.
Lead Equipment, Utility, and Facility Qualification activities, including IQ, OQ, and PQ execution.
Manage Cleaning Validation activities, including protocol development, execution, sampling coordination, and final reporting.
Support validation for CIP, SIP, sanitization, and sterilization systems.
Coordinate validation testing activities with Engineering, Quality, and Operations teams.
Author and review validation protocols, summary reports, deviation investigations, and change control documentation.
Ensure all validation activities are compliant with cGMP requirements and applicable regulatory standards.
Provide technical guidance and defend validation approaches during audits and internal reviews.
Drive continuous improvement initiatives related to validation systems, processes, and documentation practices.
Required Qualifications
7+ years of validation experience within pharmaceutical, biotechnology, or regulated life sciences manufacturing.
Strong experience in equipment qualification and lifecycle validation (IQ/OQ/PQ).
Hands-on expertise in cleaning validation, including methodology development and acceptance criteria.
In-depth understanding of validation principles, cGMP regulations, and industry compliance standards.
Strong technical writing skills with experience preparing validation protocols, reports, and supporting documentation.
Excellent communication and cross-functional collaboration skills.
Ability to manage multiple validation projects in a fast-paced manufacturing environment.
Availability to work onsite as required.
Preferred Qualifications
Experience supporting commercial-scale manufacturing operations.
Knowledge of CIP, SIP, sterilization, and sanitization validation processes.
Strong problem-solving and deviation management experience.
Experience supporting inspection readiness and regulatory audits.
