Job Description
Roles & Responsibilities:
We are seeking a seasoned Validation Engineer with + years of experience in medical device or regulated manufacturing environments. Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP . A solid working knowledge of regulatory frameworks is essential — specifically ISO , ISO , EU IVDR /, and FDA CFR — along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs. Experience with PFMEA and change control impact assessments is also expected. On the analytical side, candidates should be proficient in statistical methods used in validation, including ...