QC Instrument Specialist

Merck; Wilmington (DE); On-site; USD 90,000 - 110,000; Full time

Job summary

Merck is establishing a Wilmington QC Instrumentation team to support the start-up and ongoing operation of analytical laboratories for high-potent biologics. The role ensures instruments are qualified, calibrated, and maintained to support regulatory and quality standards.

Reporting to the QC Instrumentation lead, you will collaborate with QA, IT, and Global Engineering Services to drive commissioning, qualification, and lifecycle management of analytical instruments in a fast-paced environment.

Qualifications

• Bachelor's degree in a related scientific discipline.
• Minimum 2 years' experience in a regulated laboratory environment.
• Experience with analytical instrumentation (HPLC/UPLC, plate readers, MS).
• Familiarity with IQ/OQ/PQ and calibration concepts.
• Exposure to GMP environments and quality systems.

Responsibilities

• Support start-up of new facility and instrument commissioning activities.
• Coordinate IQ/OQ/PQ protocols and qualification documentation.
• Maintain instrument status, deviations, and change controls in the quality system.
• Troubleshoot instrument issues and coordinate repairs with vendors.
• Collaborate with QA, IT, GES and cross-functional teams to ensure readiness.

Skills

Attention to detail

Troubleshooting

Documentation

Education

Bachelor's degree in Chemistry/Biochemistry/Engineering

Tools

Empower

Softmax Pro

GLIMS

LabX

MODA

Biovia

SAP

Veeva

Job description

Job DescriptionAt 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.

Job DescriptionAt 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. This 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. Wilmington Biotech Campus – Quality Control Laboratory The Quality Control (QC) Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. Reporting to the QC lead for Instrumentation & Digital Systems, the Quality Control Instrument Specialist will support the start-up and ongoing operation of new laboratory facilities by assisting with the 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 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

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, 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.

Core Competencies And Skills

• Strong attention to detail and documentation practices
• Strong critical thinking skills and troubleshooting capabilities
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