Our pharmaceutical client is seeking a CQV Validation Engineer to join their team in Andover, MA. This role will focus on the commissioning, qualification, and validation (CQV) of 20 freezers and chambers to ensure they meet all quality and regulatory standards. The ideal candidate will work closely with cross-functional teams to develop and execute comprehensive validation protocols across these critical systems.
Key Responsibilities
o Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for the assigned freezers and environmental chambers.
o Oversee and manage the complete validation lifecycle to ensure equipment performs as specified.
o Prepare, review, and maintain detailed validation documentation in compliance with cGMP, FDA, and other applicable regulatory guidelines.
o Ensure all validation reports are thorough, accurate, and audit ready.
o Work closely with Quality Assurance, Engineering, and Operations teams to integrate validation activities into ongoing projects.
o Coordinate with external vendors and contractors as necessary to facilitate validation tasks and equipment modifications.
o Identify, document, and resolve any issues encountered during the validation process.
o Implement process improvements based on testing outcomes and industry best practices.
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Bachelors degree in Engineering, Life Sciences, or a related field.
Proven experience in CQV activities within the pharmaceutical or life sciences industry.
Detailed knowledge of validation protocols (IQ/OQ/PQ) and regulatory requirements (e.g., cGMP, FDA guidelines).
Strong analytical, troubleshooting, and project management skills.
Excellent written and verbal communication skills.
Experience with LLAB software
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.