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 operationsReview validation procedures and completed protocols for accuracy, completeness, and GMP complianceMaintain the validated state of QC equipment in accordance with corporate and regulatory requirementsSupport 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 equipmentOwn and manage change control processes for QC equipmentAct as project manager, driving and implementing equipment validation and qualification effortsCollaborate with IT, Metrology, and cross‐functional stakeholders to ensure successful project deliveryEnsure deliverables meet quality, timeline, and cost expectationsAuthor and present technical and scientific documentation and reportsSupport lifecycle management and functionality of QC laboratory systems and equipmentQualifications 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) preferredSAP PM and QM module experience a plusUnderstanding of QC equipment, system functionality, and lifecycle management preferredStrong technical writing and communication skills preferredCompensation for the Senior Validation & Quality Engineer:* Salary Range: $90K - $120K/year* Full benefits including Cigna Health, Dental, Vision, and sick leave as required by lawApplications: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#LI-KI1 #LI-ONSITE