Validation Engineer

2 days ago

Holly Springs, North Carolina, United States Piper Companies Full time

Piper Companies is seeking a Validation Engineer for an advanced biologics CDMO located in Holly Springs, North Carolina (NC). The ideal Validation Engineer will have experience working in validation and/or process engineering, filling line experience, and be a self-motivated individual with the ability to own projects. This is an on-site position in Holly Springs, NC.

Responsibilities of the Validation Engineer:

  • Execute IQ/OQ/PQ validation protocols for parenteral filling and automated inspection equipment.
  • Collaborate with cross-functional teams on new line installations, process improvements, and equipment commissioning.
  • Take technical ownership of key validation projects, driving timelines and deliverables.
  • Optimize performance of automated inspection systems through hands-on troubleshooting and continuous improvement.
  • Contribute to the development and refinement of validation strategies as part of the Performance Qualification (PQ) team.
  • Support documentation efforts using Kneat or similar platforms; training available for motivated learners.

Qualifications for the Validation Engineer:

  • 5–10 years of experience in validation, process engineering, or CQV within sterile manufacturing environments.
  • Proven ability to independently author and execute validation protocols.
  • Extensive hands-on experience with aseptic filling lines.
  • Skilled in equipment troubleshooting and execution—comfortable working directly with machinery.
  • Self-motivated "doer" with a proactive mindset and strong ownership of tasks.
  • Familiarity with automated inspection systems is a plus.

Compensation for the Validation Engineer:

  • Salary Range: $60-$70/hour dependent on experience
  • Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 10/13/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV Engineer, Validation Engineer, Sterile Manufacturing, Aseptic Filling, Aseptic Processing, Equipment Qualification, IQ/OQ/PQ Protocols, Automated Inspection Systems, Hands-on Troubleshooting, Performance Qualification (PQ), Cross-functional Collaboration, Equipment Commissioning, Continuous Improvement, Kneat Validation Software, GMP Compliance, Pharmaceutical Engineering, Technical Ownership, Self-starter, Cleanroom Environment

#LI-GP2 #LI-ONSITE

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