QC Laboratory Instrument, Senior Specialist

Job Overview

We are committed to keeping the patient at the heart of all our work and striving to find solutions for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in manufacturing biologics‑based medicines, including immuno‑oncology, and will serve as a significant supplier of Antibody Drug Conjugates (ADCs) and high‑potent compounds. This facility will support the future supply of new biotechnology products to our global network.

• Support planning and execution of laboratory instrumentation procurement, installation, commissioning, and qualification activities in collaboration with Engineering, Quality Assurance, and Information Technology.
• Author and approve commissioning and qualification protocols and reports.
• Lead interactions with instrument vendors, qualification service providers, and external laboratory support groups to ensure timely execution.
• Coordinate cross‑functionally with Quality, Global Engineering Services, and laboratory operations to align commissioning and qualification timelines with overall project milestones.
• Support the design of laboratory facilities to incorporate instrumentation requirements and functionalities.

• Develop and implement maintenance and calibration strategies that meet business needs and comply with industry and regulatory expectations.
• Maintain accountability for the ongoing validated and calibrated state of laboratory instrumentation in support of analytical testing.
• Support activities associated with the instrument management quality system, including inventory, lifecycle documentation, periodic reviews, and decommissioning processes.
• Lead root‑cause investigations for instrument‑related deviations and implement corrective/preventive actions.
• Own instrument‑related change controls and ensure all laboratory instruments and systems are inspection‑ready at all times.
• Drive continuous improvement of instrumentation processes, leveraging new technologies and best practices.

• Lead the development of instrument‑related documentation including SOPs, policies, and work instructions.
• Ensure full compliance with Data Integrity requirements across all instrumentation and connected systems.
• Serve as a subject‑matter expert during health authority inspections.
• Support implementation and optimization of laboratory IT systems and their connectivity to laboratory instrumentation.

• Mentor and provide technical guidance to junior instrument specialists and laboratory personnel.
• Support recruitment and training of instrument support personnel.
• Lead cross‑functional project teams to drive right‑first‑time execution of instrumentation projects.
• Demonstrate change leadership by driving positive improvements in laboratory instrumentation practices.

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred).

• 6–8 years of industry experience working directly in QC testing, instrumentation, and/or technology transfer in a regulated pharmaceutical/biotech environment, with at least 4 years of direct experience in analytical instrumentation commonly used in QC laboratories.
• Strong quality background with demonstrated experience supporting or defending content during health authority inspections.
• Extensive experience with laboratory instrument commissioning and qualification (IQ/OQ/PQ) and with laboratory start‑up projects.
• Proven experience with development and management of maintenance/calibration programs.
• Experience with cGMP environments and quality management systems.
• Familiarity with core laboratory & quality systems including Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva, etc.

• Deep knowledge of Data Integrity principles and their application to laboratory instrumentation.
• Experience with implementation and optimization of laboratory IT systems (e.g., LIMS, SAP, ELN).
• Prior experience with paperless laboratory environments and digital connectivity.
• Cros…