QC Validation Engineer

Location: Clayton

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.

/OQ/PQ, FAT, SAT, Change Control, Intralogistics, Material Handling Automation

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