A leading biopharmaceutical manufacturer in Holly Springs, NC is seeking a skilled and hands-on Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) 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.

QUALIFICATIONS OF THE VALIDATION ENGINEER:

• 5–10 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 is a plus.
• Demonstrated ability to own projects and deliver results in a fast-paced, evolving environment.

• 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).