CQV Engineer

ZP Group•Holly Springs, NC

34d•$55 - $65•Onsite

About The Position

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!

Requirements

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.
Demonstrated ability to own projects and deliver results in a fast-paced, evolving environment.

Nice To Haves

Experience with automated inspection systems and KNEAT validation is a plus.

Responsibilities

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).