Piper Companies is seeking a
Senior Validation Engineer to support a global pharmaceutical manufacturing organization in Clayton, North Carolina. This
Senior Validation Engineer will play a critical role in leading validation efforts for capital projects, equipment implementations, automation initiatives, and manufacturing process improvements within a highly regulated GMP environment. This is a long-term contract opportunity expected to run from December 2026 through November 2028 and requires full-time onsite presence.
Responsibilities- Lead validation strategy and execution for manufacturing systems, equipment, automation platforms, and production processes, ensuring successful completion of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) activities.
- Develop, review, and approve key lifecycle validation deliverables including Validation Plans, Project Quality Master Plans, protocols, reports, risk assessments, and supporting technical documentation.
- Drive investigation activities related to validation discrepancies, deviations, and non-conformances, utilizing structured root cause analysis methodologies to identify corrective actions and prevent recurrence.
- Partner with project teams during FAT, SAT, commissioning, startup, and qualification activities while maintaining ownership of validation deliverables, change requests, and compliance requirements.
- Provide leadership for validation workstreams, including project coordination, contractor oversight, schedule management, budget tracking, status reporting, and continuous improvement initiatives.
Qualifications- Minimum of 7 years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments, with significant exposure to automated manufacturing systems.
- Demonstrated expertise authoring and executing validation documentation throughout the equipment and process lifecycle, including IV, OV, PV, commissioning, qualification, and change control activities.
- Strong background conducting systematic troubleshooting, deviation investigations, and root cause analysis within GMP-regulated operations.
- Proven project leadership experience with the ability to manage multiple validation projects simultaneously while collaborating effectively with engineering, operations, quality, and manufacturing stakeholders.
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred. Working knowledge of GAMP 5, 21 CFR Part 11, FDA regulations, ICH guidelines, electronic records systems, and quality management principles is highly desired.
Compensation- Salary Range: $160,000 - $170,000 annually
- Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
Application Details- Location: Clayton, NC
- Work Schedule: 100% Onsite (5 Days per Week)
- Employment Type: Contract
- Contract Duration: December 2026 - November 2028
- Posting Date: 10.6.26
KeywordsSenior Validation Engineer, Validation Engineering, Pharmaceutical Manufacturing, GMP, CQV, Commissioning, Qualification, Equipment Validation, Process Validation, IV, OV, PV, Change Control, CAPA, Root Cause Analysis, Deviation Investigation, GAMP 5, 21 CFR Part 11, FDA Compliance, ICH Guidelines, Automation Validation, Manufacturing Systems, FAT, SAT, Project Leadership, Engineering Projects, Quality Systems, Validation Lifecycle, Technical Documentation, Risk Assessment, Commissioning Activities, Capital Projects, Pharmaceutical Equipment, Process Improvement, Contractor Management, Compliance Review, Manufacturing Operations, Validation Plans, Quality Master Plans, Regulated Environment, Continuous Improvement
