Senior Validation & Quality Engineer

Senior Validation & Quality Engineer

We are seeking a highly skilled and detail‑oriented Senior Validation & Quality Engineer to support validation and compliance activities for advanced automation and intralogistics systems at a new greenfield pharmaceutical manufacturing site in Clayton, NC
. This role is hands‑on and critical to ensuring an audit‑ready validation program supporting fully automated material‑handling operations across the FFEx facility.

• Provide validation and technical support through preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
• Author and maintain essential validation documents including PQMPs, Validation Plans (VPLs), Change Requests (CRs), and Configuration Item Lists (CILs)
• Perform compliance and technical reviews/approvals of protocols and protocol data
• Ensure all validation protocols and activities follow corporate, regulatory, and local requirements (FDA, ICH, GAMP5, 21 CFR Part 11, ISO)
• Lead validation failure investigations and non‑conformities using structured root‑cause analysis techniques
• Write, review, and maintain specifications, procedures, and supporting documentation needed to maintain equipment and system validated states
• Participate in FAT/SAT, commissioning, and transition newly delivered equipment/automation systems into validation ownership
• Support large‑scale intralogistics systems including ASRS, automated conveyors, AGVs/AMRs, and integrated IT/OT layers such as SCADA, WCS, and SAP
• Identify process improvements and ensure readiness prior to systems entering change control
• Provide oversight for contractors and assist with validation‑related budget tracking as required
• Lead validation activities assigned by the project manager and act as SME for new systems
• Maintain complete and audit‑ready documentation throughout all validation stages

• BA/BS degree in Engineering, Computer Science, or relevant technical field (or equivalent experience)
• MA/MS/MBS degree preferred
• Minimum 7 years of validation or quality experience in the pharmaceutical industry
• 3–5 years of experience with robotics, automation, and SAP (preferred)
• Strong knowledge of regulatory standards including 21 CFR Part 11, GAMP5, ISO, and FDA/ICH guidance
• Demonstrated experience conducting root‑cause analysis and solving complex technical problems
• Ability to read, write, and understand complex equipment and product documentation
• Strong leadership, communication, and project management abilities
• Experience writing technical documentation based on equipment manuals
• Prior pharmaceutical manufacturing experience preferred; strong understanding of GMP concepts required
• Ability to manage multiple deadlines and adapt to changing process priorities
• Strong change management experience (Novo Nordisk experience is a plus)

• $60–$70/hour
• Full benefits including Cigna Health, Dental, Vision, and sick leave as required by law

Applications will be accepted on a rolling basis and remain open for at least 30 days from posting.

Validation, Quality Engineering, GMP, cGMP, SCADA, WCS, SAP, ASRS, AGV, AMR, Automation, Robotics, Pharmaceutical, FDA, GAMP5, IQ/OQ/PQ, FAT, SAT, Change Control, Intralogistics, Material Handling Automation