Validation Engineer Lead

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.   Key Responsibilities: - Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment. - Coordinate FAT/SAT execution and documentation with vendors and engineering teams. - Perform field inspections, loop checks, and functional verifications during commissioning. - Ensure equipment is installed and operates per design specifications, user requirements, and cGMP standards. - Support resolution of deviations and discrepancies identified during commissioning and qualification. - Author and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports. - Interface with validation, manufacturing, automation, and QA to ensure alignment and timely execution of CQV activities. - Participate in change control evaluations and equipment impact assessments.Downstream Equipment in Scope: - Chromatography Skids. - Tangential Flow Filtration (TFF) systems. - Depth filtration units. - Centrifuges and continuous flow centrifuges. - Virus filtration and inactivation systems. - Bulk product hold tanks and transfer skids. - Clean-in-place (CIP) and Steam-in-place (SIP) systems. Qualifications: - Bachelor’s degree in engineering, biotechnology, or related life sciences discipline. - 3–7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment. - Strong understanding of downstream unit operations and associated automation. - Proficient in writing and executing validation protocols and working within electronic validation systems (e.g., Valgenesis, Kneat). - Familiarity with FDA, EMA, and ICH guidelines. - Excellent communication and documentation skills.Preferred Skills: - Experience with single-use technologies (SUT) in downstream processing. - Knowledge of DeltaV, Rockwell, or Siemens PLC-based automation systems. - Experience working on greenfield or facility expansion projects.