Senior Validation Engineer - CQV
Confirmed on the employer's own hiring board on Nov 11, 2026. First seen by Alion on Nov 10, 2026. Dawar Consulting scores B on the Alion truth index.
Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K
Job Summary: The role will focus on equipment qualification and cleaning validation activities supporting commercial stainless steel and single-use manufacturing operations. The ideal candidate will have 8-10+ years of hands-on validation engineering experience in a cGMP biopharmaceutical manufacturing environment, with expertise in equipment qualification, CIP/SIP systems, and cleaning validation.
Key
Responsibilities Author, review, and execute equipment qualification protocols, including IQ, OQ, and PQ. Develop and execute cleaning validation and cleaning verification protocols. Perform sampling activities, visual inspections, and coordinate analytical testing, including TOC, conductivity, bioburden, and endotoxin. Support qualification of biopharmaceutical manufacturing equipment, including bioreactors, chromatography skids, TFF systems, and autoclaves. Evaluate validation results against established acceptance criteria. Troubleshoot execution discrepancies and prepare protocol exceptions in collaboration with cross-functional teams. Maintain accurate validation documentation and records in compliance with cGMP and company quality standards. Support continuous improvement initiatives within validation processes. Required
Qualifications Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline. 8-10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotechnology manufacturing facility. Hands-on experience authoring and executing equipment qualification protocols (IQ/OQ/PQ). Direct experience with cleaning validation and cleaning verification. Working knowledge of CIP/SIP systems, residue limits, and recovery studies. Experience with stainless steel and single-use manufacturing equipment. Knowledge of GMP requirements and validation documentation practices. Preferred Technical Experience Bioreactors and fermentation systems Chromatography skids Tangential Flow Filtration (TFF) systems Autoclaves TOC and conductivity testing Bioburden and endotoxin testing Cleaning validation sampling plans and analytical data review If interested, please share your updated resume at [email protected]/[email protected]