Validation Engineer

Job Description: We are looking for an experienced Validation Engineer with a strong background in sterile manufacturing environments. The ideal candidate should have hands-on experience in performing and documenting validation activities, ensuring compliance with cGMP and regulatory requirements. Key Responsibilities: Execute and document validation activities including: Equipment Qualification (IQ/OQ/PQ) Autoclave Qualification HVAC Qualification Smoke Studies Cleaning Validation Prepare and review validation protocols and reports. Coordinate with cross-functional teams (Production, Quality Assurance, Engineering) to ensure validation readiness. Ensure compliance with current regulatory guidelines (USFDA, EU GMP, WHO). Conduct periodic re-validation and maintain validation master plan documentation. Support audit readiness and respond to audit observations related to validation activities. Required Skills & Experience: Experience: 4 – 8 years in validation within a sterile/aseptic manufacturing setup. Qualification: B.E/B.Tech in Mechanical, Electrical, Instrumentation, or Chemical Engineering / M.Sc. in related discipline. Technical Skills: Knowledge of cGMP, equipment qualification procedures, and validation documentation practices. Soft Skills: Strong analytical, documentation, and communication skills.