Piper Companies
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 :
This job opens for applications on 08/18/2025. 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
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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.
- 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.
- 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 08/18/2025. 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