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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