Validation/CQV Engineer
Ohio, United States
Contract
Onsite
1 month ago
About the role
Job Summary:
We are seeking a Validation/CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and processes within a regulated manufacturing environment. The ideal candidate will be responsible for executing validation protocols, maintaining compliant documentation, and supporting testing activities for automated manufacturing and packaging equipment.
Key Responsibilities:
Qualifications:
We are seeking a Validation/CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and processes within a regulated manufacturing environment. The ideal candidate will be responsible for executing validation protocols, maintaining compliant documentation, and supporting testing activities for automated manufacturing and packaging equipment.
Key Responsibilities:
- Author, review, edit, and execute commissioning, qualification, and validation (CQV) documentation.
- Execute test scripts and accurately document testing results.
- Support validation activities for manufacturing equipment, packaging lines, systems, and software.
- Perform I/O testing, verify sensors, confirm part numbers, and troubleshoot automated equipment.
- Read and interpret technical schematics and engineering drawings.
- Maintain detailed and compliant validation records in accordance with GMP and Good Documentation Practices (GDP).
- Ensure assigned tasks are completed within project timelines and schedules.
- Collaborate with cross-functional teams including engineering, manufacturing, and quality teams.
Qualifications:
- Bachelor’s Degree or equivalent experience required.
- Prior experience in validation, qualification, commissioning, or testing activities preferred.
- Experience within pharmaceutical, medical device, combination product, or regulated packaging environments is a plus.
- Proficiency with Microsoft Office tools, especially Word, Excel, and PowerPoint.
- Strong technical documentation and report-writing skills.
- Knowledge of GMP and Good Documentation Practices (GDP).
- Strong problem-solving, organizational, and communication skills.
- Ability to work independently and effectively within a team environment.
- Strong attention to detail and time management skills.
Skills
Quality Assurance