CQV Engineer
About the Opportunity
We are seeking a CQV Engineer to support commissioning, qualification, and validation activities within a regulated manufacturing environment. This position works closely with engineering, quality, and operations teams to ensure new and existing equipment, utilities, and processes meet regulatory and operational requirements. The ideal candidate enjoys collaborating across functions, solving technical challenges, and contributing to continuous improvement initiatives that support product quality and patient safety.
Key Responsibilities
- Collaborate with engineering, quality assurance, validation, and manufacturing teams to support project execution and operational readiness
- Evaluate, troubleshoot, and optimize equipment, systems, and manufacturing processes
- Develop, review, and execute commissioning and qualification documentation including IQ, OQ, and PQ protocols
- Assess potential quality and compliance risks and implement appropriate mitigation strategies
- Prepare validation summaries, technical reports, and supporting compliance documentation in accordance with applicable regulatory requirements and GMP standards
- Investigate, document, and resolve deviations, discrepancies, and nonconformance events identified during qualification activities
- Assist in the development and maintenance of engineering documents, user requirement specifications, and design qualification packages
- Support continuous improvement efforts aimed at enhancing system performance, reliability, and compliance
Qualifications
- Technical or engineering education preferred
- Hands-on experience with commissioning, qualification, validation (CQV), and temperature mapping activities
- Knowledge of current regulatory standards and industry guidance, including FDA, ICH, ISPE, and ISO requirements
- Proficiency with Microsoft Office applications, particularly Word and Excel
- Strong analytical and problem-solving abilities with a collaborative approach to working across departments
- Excellent written and verbal communication skills with a strong attention to detail
- Passion for process improvement, quality systems, and supporting the development and manufacture of regulated products
FAQs
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