Job Overview
We seek a Manufacturing Validation Specialist to support the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing.
* Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
* Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
Key Responsibilities
* Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
* Support clean utilities qualification, such as WFI, clean steam, compressed air, and HVAC.
* Ensure validation of automation and control systems, including SCADA, PLC, and MES where applicable.
* Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
* Support audits and regulatory inspections by providing validation data and technical justifications.
Requirements
* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
* 5-7 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
* Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
* Familiarity with Process Analytical Technology (PAT) and digital validation tools.