QC Instrument Specialist

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. Quality Control Instrument Specialist – Role Reporting to the QC lead for Instrumentation & Digital Systems, the Quality Control Instrument Specialist supports the start‑up and ongoing operation of new laboratory facilities by assisting with procurement, commissioning, qualification, and lifecycle management of analytical instrumentation. This role ensures that laboratory instruments are maintained in a validated and calibrated state to support analytical testing in compliance with regulatory and quality standards. Key Accountabilities New Facility & Laboratory Start‑up Support procurement and installation of laboratory instrumentation, coordinating 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 (SOPs, maintenance plans, equipment classifications, and qualification documentation). Coordinate with QA, IT, and Global Engineering Services (GES) functions to ensure commissioning and qualification activities are completed on schedule. 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, documenting 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 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 research, IT, QA, and engineering. Support training activities for laboratory personnel on instrument operation and maintenance. Contribute to continuous improvement initiatives for instrumentation processes. Qualifications / Experience Education Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline. Experience 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). 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. Core Competencies and Skills 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. Additional Information Location: Wilmington, Delaware (On‑Site). Travel: Ability to travel ~10% of the time. Salary range: $87,300 – $137,400. Employee status: Regular. Relocation: No relocation assistance. VISA sponsorship: No. Travel requirements: 10%. Flexible work arrangements: Not applicable. Shift: 1st – Day. Valid driving license: No. Hazardous Material(s): Yes. Salary & Benefits The salary range for this role is $87,300.00 – $137,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits can be found at Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process, please contact us. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr Merck & Co.