Validation Specialist

About the role

A growing pharmaceutical manufacturer is seeking a Validation Specialist / Validation Engineer to support qualification, validation, and lifecycle management activities across a sterile injectable manufacturing facility. This individual will play a key role in ensuring manufacturing equipment, utilities, facilities, processes, and systems remain compliant with cGMP and regulatory requirements while supporting ongoing site growth and operational readiness.

Responsibilities

• Execute and maintain qualification and validation programs across manufacturing, utilities, facilities, and laboratory systems
• Author, review, and execute validation protocols, reports, and associated documentation
• Support equipment qualification activities including IQ, OQ, PQ, and requalification programs
• Perform validation activities for manufacturing equipment, process systems, and utility systems
• Support process validation, media fills, and cleaning validation programs
• Conduct risk assessments and validation impact assessments related to change controls
• Investigate validation-related deviations and implement corrective actions
• Review validation data and prepare summary reports
• Maintain validation schedules and support ongoing compliance activities
• Partner closely with Engineering, Manufacturing, Quality, Microbiology, and Quality Control teams
• Support internal audits, customer audits, and regulatory inspections
• Ensure validation documentation remains inspection-ready and compliant with cGMP requirements

Requirements

• Bachelor's degree in Engineering, Chemistry, Pharmacy, Biotechnology, Microbiology, Life Sciences, or a related discipline
• 5+ years of validation experience within pharmaceutical manufacturing
• Experience supporting GMP-regulated manufacturing facilities
• Hands-on experience executing IQ/OQ/PQ activities
• Strong technical writing and documentation skills
• Experience supporting investigations, deviations, and change controls
• Strong understanding of validation lifecycle principles and regulatory expectations
• Excellent communication and cross-functional collaboration skills

Preferred Qualifications

• Sterile injectable manufacturing experience
• Process validation experience
• Equipment qualification experience
• Utility qualification experience (WFI, Purified Water, HVAC, Clean Steam, Compressed Air)
• Cleaning validation experience
• Media fill support experience
• Knowledge of FDA regulations, cGMP, Annex 1, and Data Integrity requirements
• Experience supporting regulatory inspections and audit readiness initiatives