Equipment Validation Engineer (CQV) (Contract) 22222

The CQV Engineer is responsible for supporting and executing Commissioning, Qualification, Validation, and Requalification activities across GMP-regulated facilities. This role involves the development and execution of validation protocols, cross-functional collaboration, and adherence to cGMP, company standards, and regulatory guidelines. The ideal candidate will have hands-on experience in protocol development and execution within a pharmaceutical or biotech environment and demonstrate the ability to work independently while managing multiple validation tasks.

Key Responsibilities:

• Develop and execute qualification and validation protocols, including IOQ and PQ documentation.
• Ensure validation activities comply with internal SOPs, global standards, and current Good Manufacturing Practices (cGMP).
• Coordinate scheduling and execution of test plans with internal teams and external vendors.
• Collaborate with cross-functional departments such as Engineering, Facilities Operations, QA, GIS, EH&S, Global Security, and PMO.
• Support safe execution of validation activities in alignment with operational and construction timelines.
• Promote a "right-the-first-time" culture and maintain documentation accuracy across all validation deliverables.
• Maintain up-to-date compliance with assigned training and documentation requirements.
• Support the reputation and integration of the Engineering team by fostering effective cross-functional partnerships.

Requirements

Required Qualifications:

• Bachelor’s degree in Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related scientific discipline.
• 2–4 years of experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated industry.
• Experience developing and executing qualification protocols in a regulated environment.
• Familiarity with Kaye Validator, data loggers, and temperature mapping equipment.
• Understanding of industry regulations and standards including GMP, ISO, GAMP, and ANSI.
• Demonstrated ability to adapt to change, solve technical problems, and troubleshoot equipment/process issues.
• Strong written and verbal communication skills.
• Self-motivated with the ability to work independently and manage multiple priorities.

Benefits

• CONTRACT