CQV Engineer
2 weeks ago
A leading biopharmaceutical manufacturer in
Holly Springs, NC
is seeking a skilled and hands-on CQV (Commissioning, Qualification, and Validation) Engineer of parenteral filling equipment and automated inspection systems. This role is ideal for a proactive self-starter who thrives in dynamic environments and enjoys being deeply involved in equipment and process execution.
Key Responsibilities of the CQV Engineer:
- Execute equipment qualification activities, with a focus on parenteral filler systems.
- Independently write, execute, and review validation protocols (IQ/OQ/PQ) for filling and packaging equipment.
- Provide hands-on troubleshooting and support for equipment and automated inspection systems.
- Collaborate with cross-functional teams to support new line installations and process improvements.
- Contribute to PQ team efforts, challenging and refining validation plans to ensure robustness.
- Fill technical gaps left by departing team members, bringing executional strength and ownership.
- Utilize systems like Kneat for documentation and protocol management (training provided if needed).
Qualifications of the CQV Engineer:
- 3-5 years of experience in validation, process engineering, or CQV within sterile manufacturing.
- Proven ability to independently write and execute validation protocols.
- Strong experience with filling lines, preferably in parenteral or aseptic environments.
- Comfortable with hands-on equipment work—troubleshooting and execution are essential.
- Self-starter with a "doer" mentality and the ability to drive tasks forward.
- Experience with automated inspection systems and KNEAT validation is a plus.
- Demonstrated ability to own projects and deliver results in a fast-paced, evolving environment.
Compensation for the CQV Engineer:
- Pay range: $55–$65/hr, based on experience and qualifications
- Benefits: Full health, dental, vision, PTO, holidays, and sick leave as required by law
Applications are now being accepted as of 10/20.
If you're ready to take ownership of impactful validation projects in a cutting-edge sterile manufacturing environment, apply today
Keywords:
CQV, Validation Engineer, Sterile Manufacturing, Aseptic Processing, Parenteral, Filling Line, Packaging Equipment, Automated Inspection Systems, IQ/OQ/PQ, Kneat, Biotech Jobs, Pharma Jobs, Engineering Contract, Holly Springs Jobs, Pharmaceutical Engineering, Process Validation
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