Validation Engineer CQV Engineer
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Job Location:
Cincinnati, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Summary:
- Support validation and commissioning/qualification/validation (CQV) activities onsite for sterile manufacturing and fill/finish operations.
- Execute hands-on OQ/PQ (Operational/Performance Qualification) protocols and equipment qualification in a GMP-regulated environment.
- Prepare and manage GMP documentation including protocol execution discrepancy/deviation resolution and qualification deliverables.
- Work independently and efficiently in a fast-paced project-driven setting.
- Perform validation activities for equipment such as autoclaves formulation equipment fill suites high-velocity fillers isolators parts washers tanks and aseptic process systems.
- Contribute expertise to fill line qualification aseptic filling and sterile manufacturing processes.
- Provide support for vision systems or automated inspection systems particularly for high-speed fill lines or aseptic production.
- Ensure accurate real-time documentation and assist with protocol closeout and deviation management.
- Collaborate with cross-functional teams to ensure compliance and timely completion of validation tasks.
- Must be local and available for a hybrid onsite role.
- Education: Bachelors degree in Engineering Life Sciences or related field preferred; equivalent hands-on validation/CQV experience in GMP environments considered.
- Strong plus: Experience with Kaye validators wireless probes SIP/VHP sterilization vision/inspection systems and comprehensive equipment qualification documentation.
- Support validation and commissioning/qualification/validation (CQV) activities onsite for sterile manufacturing and fill/finish operations.
- Execute hands-on OQ/PQ (Operational/Performance Qualification) protocols and equipment qualification in a GMP-regulated environment.
- Prepare and manage GMP documentation including protocol execution discrepancy/deviation resolution and qualification deliverables.
- Work independently and efficiently in a fast-paced project-driven setting.
- Perform validation activities for equipment such as autoclaves formulation equipment fill suites high-velocity fillers isolators parts washers tanks and aseptic process systems.
- Contribute expertise to fill line qualification aseptic filling and sterile manufacturing processes.
- Provide support for vision systems or automated inspection systems particularly for high-speed fill lines or aseptic production.
- Ensure accurate real-time documentation and assist with protocol closeout and deviation management.
- Collaborate with cross-functional teams to ensure compliance and timely completion of validation tasks.
- Must be local and available for a hybrid onsite role.
- Education: Bachelors degree in Engineering Life Sciences or related field preferred; equivalent hands-on validation/CQV experience in GMP environments considered.
- Strong plus: Experience with Kaye validators wireless probes SIP/VHP sterilization vision/inspection systems and comprehensive equipment qualification documentation.
