Validate Equipment Effectively
An exciting opportunity exists for a skilled CQV Engineer to develop and execute validation protocols for equipment and systems across various industries.
* Develop, implement, and maintain comprehensive CQV protocols (IQ/OQ/PQ) for equipment and systems
* Evaluate and ensure compliance with strict quality standards, including GMP and FDA regulations
* Collaborate closely with cross-functional teams, vendors, and clients to deliver high-quality CQV outcomes
Key Responsibilities:
* Prioritize and manage multiple projects simultaneously, ensuring timely completion of CQV deliverables
* Develop strong relationships with project stakeholders, fostering open communication and collaborative problem-solving
* Stay up-to-date with industry developments, best practices, and regulatory requirements, applying this knowledge to improve CQV processes
Required Skills and Qualifications:
* A minimum of 5 years of experience in CQV, preferably in Biopharma or Pharmaceutical projects
* Proven expertise in one or more areas, including Upstream (Bioreactors, media prep), Downstream (Chromatography, Filtration), Utilities (WFI, Clean Steam, HVAC), and CIP Systems
* Demonstrated understanding of GMP regulations, validation principles, and quality control procedures