Biotech QC Instrumentation Specialist

Merck

Wilmington (DE)

On-site

USD 90,000 - 110,000

Full time

23 hours ago

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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.