We are working with a pharmaceutical manufacturing company who is seeking a CQV Validation Engineer 2 to support and collaborate with their current clients.
This company's core mission is to drive growth and spark innovation within the scientific community, aiding researchers, organizations, and companies in solving some of the world's most urgent healthcare problems.
Key Responsibilities:
- Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
- Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
- Running test scripts and documenting results.
- Adherence with project schedule for all assigned activities.
Key Requirements:
- Must be willing to work onsite in Cincinnati, OH
- Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
- Minimum 4 years technical experience.
- Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
- Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
- Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
If you think you'd be a good fit for this role and like to learn more, please respond with your resume and availability to chat.
