What are the responsibilities and job description for the CQV Engineer/Validation Engineer 2 position at EPM Scientific?
Are you an experienced CQV Engineer / Validation Engineer 2 looking for your next opportunity? This is a key role in ensuring the quality and compliance of cutting-edge equipment, systems, and processes in a GMP-regulated environment. Responsibilities and Qualifications would include :
- Author, edit, and execute technical commissioning, qualification, and validation (CQV) documentation for equipment, systems, software, and processes as part of a project team.
- Run test scripts and document results accurately.
- Ensure adherence to project schedules for all assigned tasks.
- Maintain clear, detailed records of qualification and validation activities.
- Document impact and risk assessments as part of a collaborative team effort.
- Perform user interface testing, software verification, and comprehensive alarm testing on automated systems.
- Develop, review, and execute testing documentation.
- Provide recommendations for design or process modifications based on test results.
- Demonstrate a general understanding of capital equipment implementation and process workflows.
- Interpret validation documents, including URS, IQ, OQ, and PQ.
- Independently understand and apply client quality standards, cGMP regulations, and other relevant regulatory requirements to ensure compliance.
- Conduct independent verification of testing against specifications.
- Collaborate with client quality representatives to investigate and resolve deviations, including performing root cause analysis.
- Support change management initiatives, including authoring proposed changes, executing impact assessments, conducting regression analysis, and documenting change outcomes.
- Verify system drawings, including reviewing and updating P&IDs (piping and instrumentation diagrams) and I&C (instrumentation and controls) drawings, with electrical schematics reviewed alongside an electrical engineer.
Requirements :
