QC Instrument Specialist

Job Overview

Job Description At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology.

This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. The facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network.

• New Facility & Laboratory Start‑Up
  • Support the procurement and installation of laboratory instrumentation, including coordination with vendors and internal stakeholders.
  • Assist with the development and execution of instrument commissioning and qualification (IQ/OQ/PQ) protocols.
  • Prepare and review supporting documentation for instrument qualification activities to ensure the highest standards of execution including SOPs, maintenance plans, equipment classifications, and qualification documentation.
  • Coordinate with Quality Assurance (QA), Information Technology (IT), and Global Engineering Services (GES) functions to ensure commissioning and qualification activities are completed on schedule to support operational readiness.
  • Support interaction with qualification services providers and external laboratory support groups.
• Post Go‑Live Instrument Lifecycle Management
  • Execute maintenance and calibration activities in accordance with established schedules and regulatory expectations.
  • Ensure all laboratory instrumentation is maintained in a fully validated and calibrated state in support of analytical testing.
  • Support the instrument management quality system, including documentation of instrument status, deviations, and change controls.
  • Assist with troubleshooting instrument issues and coordinating repairs with vendors.
  • Maintain inspection readiness of all laboratory instruments and systems at all times.
• Quality & Compliance
  • Support the development and maintenance of instrument‑related SOPs, work instructions, and quality system documentation in compliance with cGMP, biosafety, corporate policies, and regulatory requirements.
  • Ensure compliance with Data Integrity and Good Documentation Practices requirements related to laboratory instrumentation.
  • Support and/or lead equipment troubleshooting and related deviations, CAPAs, and change controls.
  • Participate in internal audits and support health authority inspections as needed.
• Collaboration & Development
  • Liaise with cross‑functional teams including our research division, IT, Quality Assurance, and Engineering Support training activities for laboratory personnel on instrument operation and maintenance.
  • Contribute to continuous improvement initiatives for instrumentation processes.

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline.
• Minimum 2 years of industry experience in a regulated laboratory environment (pharmaceutical, biotech, or related industry).
• Experience with analytical instrumentation commonly used in QC laboratories (e.g., HPLC/UPLC, plate readers, mass spectrometers, analytical balances, etc.).
• Familiarity with instrument qualification (IQ/OQ/PQ) and calibration principles.
• Exposure to GMP environments and quality management systems is required.
• Experience with core laboratory & quality systems including Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva, etc.

• Strong attention to detail and documentation practices.
• Strong critical thinking skills and troubleshooting capabilities.
• Good organizational and time management skills.
• Ability to work collaboratively in a team environment.
• Basic understanding of Data Integrity principles.
• Familiarity with laboratory IT systems and electronic data management.
• Effective written and verbal communication skills.

• Location:
  
  Wilmington, Delaware…