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.

Key Responsibilities of the Senior Validation & Quality Engineer:

• 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

Qualifications of the Senior Validation & Quality Engineer:

• 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)

Compensation for the Senior Validation & Quality Engineer:

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

Applications:

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

Keywords: 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

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