Validation Engineer

We are seeking an experienced Validation Engineer with strong Change Management / Change Control experience to support controlled-temperature equipment and GMP validation activities within a pharmaceutical or biotechnology manufacturing environment. The ideal candidate will have hands-on experience supporting CTU/CTE activities, stability chambers, freezers, refrigerators, and other temperature-controlled equipment, along with strong knowledge of GMP change control processes, qualification documentation, risk assessments, deviations, and lifecycle management. This individual will work closely with Quality, Validation, Engineering, Manufacturing, Facilities, and Laboratory teams to ensure equipment changes are appropriately assessed, documented, qualified, and maintained in a validated state. Key Responsibilities Manage and support Change Control / Change Management activities associated with GMP equipment, laboratory systems, utilities, and controlled-temperature units. Initiate, assess, execute, and close change controls in accordance with site Quality Management System requirements. Support CTU and CTE qualification and validation activities. Stability chambers Walk-in chambers Cold rooms Incubators Other controlled-temperature storage systems Develop, review, and execute qualification protocols including IQ, OQ, PQ and requalification activities. Support temperature mapping studies and evaluate temperature distribution, hot/cold spots, alarm settings, and acceptance criteria. Develop and review validation protocols, reports, risk assessments, traceability documentation, and supporting technical documentation. Assess equipment modifications and determine the appropriate validation or requalification impact. Perform change impact assessments related to equipment, facilities, utilities, processes, and computerized or monitoring systems. Coordinate change implementation activities with Engineering, Facilities, Quality, Validation, Manufacturing, and laboratory personnel. Ensure all required validation deliverables are completed prior to Change Control closure. Support deviations, investigations, CAPAs, and corrective actions associated with qualification or temperature-controlled equipment. Review discrepancies encountered during protocol execution and assist with root-cause investigations. Support calibration, preventive maintenance, alarm verification, and equipment lifecycle activities where applicable. Ensure equipment remains in a validated and compliant state following modifications, repairs, upgrades, or relocation. Support periodic review and requalification programs for GMP equipment. Maintain accurate documentation in accordance with cGMP, GDP, data integrity, and site procedures. Participate in inspection-readiness activities and support internal, client, and regulatory audits. Required Qualifications Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline. Approximately 5+ years of validation, qualification, engineering, or quality experience within pharmaceutical, biotechnology, or another GMP-regulated environment. Strong hands‑on experience with Change Control / Change Management. Hands‑on experience with stability chambers, freezers, refrigerators, cold rooms, or similar temperature‑controlled equipment. Experience developing and executing IQ/OQ/PQ protocols and qualification reports. Understanding of temperature mapping and controlled‑temperature equipment qualification. Experience performing validation impact assessments and risk assessments. Familiarity with deviations, CAPAs, investigations, and GMP documentation. Strong knowledge of cGMP requirements and Good Documentation Practices. Ability to independently manage validation/change‑control deliverables and coordinate across multiple functional teams. #J-18808-Ljbffr