Senior CQV Engineer / Validation Lead

Role Overview

• The Senior CQV Engineer / Validation Lead will be responsible for the planning, authoring, execution, and completion of Commissioning, Qualification, Validation (CQV), and Process Qualification activities associated with laboratory, manufacturing, and process equipment.
• This is a hands-on role requiring the individual to independently develop validation documentation, execute qualification protocols, manage deviations, analyze results, and prepare final reports while coordinating activities with Engineering, Manufacturing, and Quality teams.
• The resource will support qualification activities for laboratory instrumentation, biosafety cabinets, labeling systems, filling and capping equipment, process equipment, bioreactors, AKTA systems, freezers, lyophilizers, autoclaves, washers, and associated manufacturing systems.

Requirements

• Bachelor's Degree in Engineering, Life Sciences, or related technical discipline.
• Minimum 810 years of CQV, Validation, Qualification, or Process Validation experience within pharmaceutical, biotechnology, or medical device environments.
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols.
• Strong knowledge of GMP regulations, FDA guidance, ASTM E2500, GAMP, and ISPE methodologies.
• Experience managing deviations, investigations, CAPAs, and Change Controls.
• Strong technical writing skills.
• Ability to work independently with minimal supervision.

Benefits

• At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens.