Validation Specialist (Vacaville)
Intellectt Inc, Vacaville, CA, United States
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.
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.