Impel Talent is exclusively supporting a confidential hiring project for a leading global pharmaceutical company undergoing rapid expansion. With over £100 million invested in state-of-the-art greenfield and brownfield projects across the US, and the EU, we are seeking an experienced Senior CQV Engineer to lead commissioning, qualification, and validation activities for a refurbishment project within New Jersey.
This is a high-impact role that will play a critical part in delivering cutting-edge pharmaceutical facilities that meet the highest regulatory standards.
Key Responsibilities
- Lead CQV activities for facilities, equipment, and utilities, ensuring compliance with cGMP, FDA, and industry regulations.
- Manage commissioning, qualification, and validation of complex engineering projects, ensuring operational efficiency and compliance.
- Collaborate with cross-functional teams to ensure GMP and HSE requirements are met from design to execution.
- Develop installation, commissioning, and validation plans, overseeing execution and documentation of protocols, impact assessments, and reports.
- Optimize project delivery by leading external qualification contractors and ensuring budget and timeline adherence.
- Act as a key liaison for regulatory audits, ensuring compliance with cGMP, FDA, and validation standards.
- Identify and implement continuous improvement strategies to enhance validation and compliance processes.
What We’re Looking For
- Degree in Engineering (Mechanical, Electrical, Civil) or a related field.
- Extensive experience in CQV, equipment qualification, and installation management within pharmaceutical or chemical manufacturing.
- Strong knowledge of cGMP, FDA, ISPE, ICH, and ISO guidelines.
- Proven ability to lead teams and manage complex, high-value engineering projects.
- Experience responding to regulatory audits and ensuring full compliance with validation requirements.
- Fluency in English and strong technical documentation skills.
Why Join?
- Work on industry-leading projects within a globally recognized pharmaceutical company.
- Competitive salary & benefits package.
- Relocation support available for the right candidate.
- Play a key role in groundbreaking facility expansion projects.
This is a confidential opportunity, and we are looking for driven professionals ready to make an impact in a dynamic and growing pharmaceutical environment.
Apply now to have a confidential discussion!
