Senior CQV Engineer ​/ Validation Lead

Responsibilities

• 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.

• 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.