QC Validation Engineer

We are seeking a highly skilled and detail‑oriented QC Equipment Validation Engineer to support laboratory validation and equipment qualification activities for a QC expansion project in Clayton, NC. This role is hands‑on and critical to ensuring a compliant, audit‑ready validation program supporting QC equipment across production, warehouse, and laboratory environments.

Key Responsibilities of the QC Equipment Validation Engineer:

• Provide validation support through preparation, execution, review, and reporting of equipment qualification activities (IQ/OQ/PQ)
• Plan, manage, and perform laboratory validation activities to support QC operations
• Review validation procedures and completed protocols for accuracy, completeness, and GMP compliance
• Maintain the validated state of QC equipment in accordance with corporate and regulatory requirements
• Support validation of a broad range of QC laboratory and facility equipment across production, warehouse, and QC areas, including analytical instrumentation, temperature‑controlled units, storage systems, and general lab equipment
• Own and manage change control processes for QC equipment
• Act as project manager, driving and implementing equipment validation and qualification efforts
• Collaborate with IT, Metrology, and cross‑functional stakeholders to ensure successful project delivery
• Ensure deliverables meet quality, timeline, and cost expectations
• Author and present technical and scientific documentation and reports
• Support lifecycle management and functionality of QC laboratory systems and equipment

Qualifications of the QC Equipment Validation Engineer:

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field (required)
• Minimum 2+ years of experience in instrument validation, laboratory validation, or engineering within pharmaceutical or related industry (required)
• Experience writing and executing validation protocols (required)
• Working knowledge of GMPs (required)
• Ability to manage projects and drive equipment validation initiatives (required)
• Experience with electronic validation systems (e.g., TIMS) preferred
• SAP PM and QM module experience a plus
• Understanding of QC equipment, system functionality, and lifecycle management preferred
• Strong technical writing and communication skills preferred

Compensation for the Senior Validation & Quality Engineer:

• Salary Range: $90K – $120K/year
• 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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