Validation Engineer
Clayton, North Carolina
Job Id:
158407
Job Category:
Job Location:
Clayton, North Carolina
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Madalyn Barry
Piper Companies is seeking a Validation Engineer to join a global leader in pharmaceutical manufacturing for an onsite 12-month contract position located in Clayton, NC. The Validation Engineer will support large-scale automation and intralogistics projects, integrating advanced material handling systems and IT/OT platforms to ensure compliance and operational excellence.
Responsibilities of the Validation Engineer include:
- Prepare, execute, analyze, and report on Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for automated systems and processes.
- Author and maintain validation documentation, including Project Quality Master Plans (PQMPs), Validation Plans (VPLs), and Change Requests (CRs).
- Lead validation investigations and non-conformities using root cause analysis techniques to ensure compliance with regulatory standards.
- Participate in FAT/SAT commissioning efforts and transition into ownership of validation activities for equipment and automation systems.
- Collaborate with cross-functional teams to identify process improvements and maintain validated states of equipment and processes.
Qualifications for the Validation Engineer include:
- Bachelor’s degree in Engineering, Computer Science, or related technical field; advanced degree preferred.
- Minimum of 7 years of validation or quality experience in a pharmaceutical environment, with strong knowledge of GMP concepts.
- 3–5 years of experience with robotics, automation, and SAP systems preferred.
- Expertise in regulatory requirements and industry standards such as 21 CFR Part 11, GAMP5, ISO, FDA, and ICH guidelines.
- Demonstrated leadership, project management skills, and ability to manage multiple priorities in a fast-paced environment.
Compensation for the Validation Engineer:
Salary Range: $125,000-$140,000/year
Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
This job opens for applications on 01/15/26. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: validation, automation, robotics, SAP, GMP, pharmaceutical manufacturing, intralogistics, ASRS, AGVs, AMRs, SCADA, WCS, root cause analysis, FAT, SAT, commissioning, regulatory compliance, GAMP5, 21 CFR Part 11, ISO standards, change control, quality assurance, project management.
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