Position Overview
The CQV Engineer is responsible for the commissioning, qualification, validation, and lifecycle management of GMP equipment, utilities, and controlled temperature storage systems. The role involves planning and executing temperature mapping studies, developing User Requirement Specifications (URS), generating qualification protocols and reports, and performing periodic reviews to ensure continued compliance with GMP and regulatory requirements.
Key Responsibilities
- Develop, execute, and document protocols (IQ, OQ, PQ) and reports for new qualification.
- Investigate and resolve discrepancies/incidents arising from qualification activities.
- Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
- Support other day-to-day validation activities, ensuring adherence to approved Validation SOPs, Plans, and Policies.
- Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.,
Required Qualifications
- Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility
- Relevant experience in validation of facility, equipment, utility, lab equipment and/or sterilization
- Familiarity with Regulatory requirements and Standards (e.g., FDA, EMEA, GAMP and ICHQ7)
- Ability to read and interpret technical documentation, system specifications, and validation protocols.
- Strong analytical, problem-solving, and organizational skills.
- Excellent communication skills and ability to work in a team-oriented environment.
- Proficiency in electronic systems such as Kneat and Trackwise will be a plus.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Willingness to learn and adapt in a fast-paced, regulated industry.
How To Apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
