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:
-Must be willing to work onsite in Cincinnati, OH.
-Bachelor's degree or equivalent experience required.
-Proven experience leading CQV activities for process equipment.
-Proficiency with Microsoft Office tools (Word, Excel, PowerPoint).
-Strong communication skills with the ability to effectively collaborate with peers and stakeholders.
-Ability to work both independently and as part of a team.
-Strong problem-solving, critical thinking, and organizational skills.
-Attention to detail and adherence to Good Documentation Practices (GDP) and GMP regulations.
-Ability to manage multiple tasks in a fast-paced, evolving environment.
-Experience working in GMP-regulated environments.
-2-4 years of relevant experience in CQV roles.
