CQV Engineer - CDMO

Posted 21 June 2024
Salary Negotiable
Job type Contract
Discipline Large Molecule
Contact NameRhys Jones

Job description

Mantell Associates is currently partnered with a global CDMO in their search for a CQV Engineer.

As CQV Engineer, you will play a critical role in ensuring the successful delivery of the pharmaceutical manufacturing site construction project in Switzerland. You will be responsible for the commissioning, qualification, and validation of all systems and equipment to ensure compliance with industry standards and regulatory requirements.

CQV Engineer - Responsibilities:

  • Develop and execute CQV protocols and plans for equipment, systems, and processes

  • Perform commissioning, qualification, and validation activities including IQ, OQ, and PQ

  • Collaborate with project managers, engineering teams, and other stakeholders to ensure project timelines and objectives are met

  • Conduct risk assessments and ensure that all CQV activities adhere to Good Manufacturing Practices (GMP) and regulatory standards

  • Prepare and review documentation, including protocols, reports, and Standard Operating Procedures (SOPs)

  • Troubleshoot and resolve issues related to equipment and systems during the CQV process

  • Ensure proper training and knowledge transfer to operational teams

  • Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in CQV.

CQV Engineer - Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or a related field

  • Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry

  • Proven experience with CAPEX projects and large-scale construction projects

  • Strong knowledge of GMP, FDA, EMA, and other relevant regulatory requirement

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.