Validation Specialist

Validation Specialist / Validation Engineer 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. Key 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 Qualifications 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 Process validation experience Utility qualification experience (WFI, Purified Water, HVAC, Clean Steam, Compressed Air) Knowledge of FDA regulations, cGMP, Annex 1, and Data Integrity requirements Experience supporting regulatory inspections and audit readiness initiatives Ideal Background Validation Specialist Validation Engineer Senior Validation Specialist Commissioning & Qualification (CQV) Engineer Process Validation Engineer Equipment Validation Engineer Qualification Engineer Validation Scientist Manufacturing Validation Specialist This opportunity is ideal for a validation professional looking to make a significant impact within a growing sterile pharmaceutical manufacturing environment while supporting critical compliance, quality, and operational initiatives. #J-18808-Ljbffr