Validation Engineer / CQV

About the Role

Our client is hiring a Validation Engineer / CQV to join their certified technology solutions and compliance consulting services company. This is a contract position requiring on-site presence.

Responsibilities

• Support commissioning, qualification, and validation activities for a new GMP facility and manufacturing areas.
• Author, review, and execute validation deliverables including MVPs, Validation Plans, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Perform cleanroom qualification activities including airflow visualization, room recovery testing, differential pressure verification, and environmental monitoring support.
• Execute qualification activities for autoclaves, parts washers, glassware washers, CTUs, process equipment, and associated utility systems.
• Perform temperature mapping studies for refrigerators, freezers, incubators, stability chambers, warehouses, and other controlled temperature storage areas.
• Support qualification of facility and utility systems including HVAC, WFI, clean steam, compressed gases, and other GMP utilities.
• Investigate protocol deviations, discrepancies, and validation issues; support impact assessments, root cause investigations, and CAPA activities.
• Review, revise, and author SOPs, work instructions, and other controlled GMP documentation to support startup and operational readiness.
• Work closely with Engineering, Facilities, Quality, Manufacturing, and vendors to support project timelines and qualification activities.
• Support change controls, commissioning turnover packages, punch list resolution, and validation lifecycle activities as required.
• Ensure all qualification and validation activities are performed in accordance with GMP requirements, site procedures, and project schedules.
• Review, execute, and provide technical sign-off on qualification documentation, including SOPs and validation protocols.
• Perform and document Performance Qualifications (PQs) for GMP manufacturing systems.
• Execute qualification activities for benchtop laboratory equipment, autoclaves, washers, filling equipment, and general manufacturing equipment.
• Support Validation Master Plan (VMP) execution and compliance activities.
• Collaborate with Quality, Manufacturing, Engineering, and Validation teams to meet project timelines.
• Provide support for sterile and non-sterile manufacturing operations.
• Contribute to process validation and cleaning validation activities as required.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline.
• 3-10 years of experience in CQV, Validation, or Pharmaceutical Manufacturing environments.
• Hands-on experience with equipment qualification (IQ/OQ/PQ) in regulated GMP facilities.
• Experience qualifying manufacturing equipment, autoclaves, washers, filling systems, and laboratory equipment.
• Knowledge of temperature mapping and qualification methodologies.
• Understanding of GxP regulations and validation lifecycle principles.
• Experience reviewing and approving validation documentation and SOPs.
• Strong technical writing and execution skills.

Preferred Qualifications

• Experience in both sterile and non-sterile pharmaceutical manufacturing environments.
• Familiarity with Validation Master Plans (VMPs).
• Process Validation experience.
• Cleaning Validation experience.
• Previous consulting or project-based validation experience.