CQV Engineer

We are seeking a highly skilled and motivated CQV Engineer to join our team for the construction and commissioning of a state-of-the-art pharmaceutical manufacturing facility. The ideal candidate will be responsible for the Commissioning, Qualification, and Validation (CQV) of all systems, utilities, and equipment to ensure compliance with industry standards, regulations, and best practices. The CQV Engineer will play a key role in the lifecycle of the project from construction to successful operational handover.

• Lead and execute commissioning, qualification, and validation activities for all systems, utilities, and equipment within the pharmaceutical manufacturing facility.
• Develop and execute comprehensive CQV plans, protocols, and reports.
• Ensure compliance with GMP (Good Manufacturing Practices), FDA, EMA, and other regulatory requirements.
• Collaborate with engineering teams to ensure systems meet design specifications and performance requirements.
• Perform functional and performance testing of utilities, HVAC, process systems, equipment, and instrumentation.
• Prepare and maintain detailed documentation, including commissioning checklists, validation protocols, deviation reports, and final validation reports.
• Review design documentation and ensure it meets applicable regulatory and operational standards.
• Track and resolve any discrepancies or non-conformances in testing or qualification activities.
• Work closely with internal teams, contractors, and external vendors to ensure timely and efficient completion of commissioning and validation activities.
• Provide guidance to junior engineers and technicians involved in CQV tasks.
• Act as the primary point of contact for all CQV-related inquiries during the construction phase.
• Ensure that all CQV activities are carried out in accordance with safety standards and environmental regulations.
• Stay updated on industry best practices, regulations, and technologies in the pharmaceutical manufacturing field.
• Identify areas for improvement in the CQV process and suggest solutions to streamline procedures, improve efficiency, and enhance compliance.
• Assist in the development and implementation of training programs for new and existing staff regarding CQV procedures.

Qualifications:

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related field).
• Minimum of 5 years of experience in CQV engineering, with a strong background in the pharmaceutical or biotechnology industry.
• Extensive knowledge of pharmaceutical manufacturing processes, equipment, and GMP regulations.
• Proficient in CQV documentation and protocols (e.g., FAT/SAT, IQ/OQ/PQ).
• Strong analytical, troubleshooting, and problem-solving skills.
• Familiarity with project management tools and techniques.
• Ability to work effectively under pressure and meet project deadlines.
• Excellent written and verbal communication skills.
• Certification in CQV (e.g., ISPE's Qualification/Validation Professional Certification).
• Experience with Cleanroom and HVAC validation.
• Knowledge of automation systems and control systems.