Digital Quality & Lab Instrument Senior Specialist

Job Description

Our Digital Quality & Lab (DQ&L), Instrument & Material Management team, operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. As we digitize and integrate analytical instruments across the enterprise, we are enabling modern, efficient, and connected laboratories that support high quality science and manufacturing.

The DQ&L Instrument Senior Specialist reports to the Laboratory Instruments & Materials Management Product Owner. The DQ&L Instrument Senior Specialist will lead implementation, configuration, and lifecycle management for analytical and analytical ancillary test instruments/systems within the digital validation system. The successful candidate will work across functional boundaries to define requirements, lead testing, execute full SDLC deliverables, and ensure compliant, efficient digital laboratory workflows to drive efficiency and compliance across our global quality and manufacturing labs.

Responsibilities

• Lead the technical implementation, configuration, and sustainment of instrument and systems across global labs
• Collaborate with laboratory users, quality teams, and IT partners to understand business processes and translate them into digital and technical requirements
• Support project completion in-line with established timescales, through collaboration with teams and cross-functional stakeholders
• Develop, execute, and maintain full SDLC documentation for laboratory instrument systems and digital integration solutions
• Revise current instrument/system specific global SDLC qualification documentation in-line with Lab Transformation program, including instrument integration
• Participate in global project teams delivering new digital capabilities and enhancements for laboratory operations
• Maintain SDLC documentation templates in-line with updates to QMS, ensuring harmonization across divisions
• Maintain a list of compliant instrument/system standards for the network
• Evaluate new instruments/systems for compliance to data integrity technical requirements and digital capabilities, ensuring software and hardware meet specifications, partnering closely with vendors and site representatives
• Lead instrument/system demonstrations in partnership with vendors and site representatives from a business use and compliance perspective
• Build and maintain strong relationships with vendors, clearly conveying our company expectations/requirements for compliant data management
  
  

Requirements

• Degree in life science (e.g. Microbiology, Chemistry, Biochemistry), IT or engineering discipline
• Strong background in pharmaceutical quality, laboratory or manufacturing operations
• Minimum of 5 years of hands-on experience supporting robust testing strategies, execution, and review of SDLC deliverables for laboratory instrumentation systems
• Deep technical & working knowledge of laboratory instrumentation standalone & client server applications i.e. LabX
• Demonstrated experience executing SDLC deliverables for standalone COTS systems in GMP environments using Digital Validation Systems e.g. Kneat eVal, X-Ray, TOSCA and Robot
• Deep understanding of computerized systems, IT, SDLC and corresponding business processes and qualification principles
• Hands‑on experience with change control, test automation, and requirements management tools
• Demonstrates a strong scientific background and takes ownership when engaging directly with laboratory instrumentation, ensuring responsibility for accurate operation, troubleshooting, and optimisation of instrument performance
• In depth knowledge of Data Integrity regulations and requirements including FDA 21 CFR Part 11, EU Annex 11 knowledge and application

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• Excellent written, verbal, and visual communication skills, with the ability to describe technical concepts to non‑technical stakeholders
• Ability to work both independently and collaboratively in a matrixed, fast‑moving environment
  
  

Nice to Haves

• Strong analytical, problem-solving and communication skills, written and verbal
• Ability to work independently and as part of a team with a customer-focused mindset
• Detail-oriented with a commitment to quality and compliance
• Proven project management skills
• Prior Experience with direct use of lab instrumentation and digital lab systems
• Working knowledge of FAIR data principles, JSON schemas, and data modeling
• Experience with instrument integration to LES systems (e.g., Biovia LES, MODA)
• Familiarity with Scitara DLX or other instrument integration middleware. AWS Associate certification or equivalent cloud experience
• Experience with Allotrope Ontologies or Allotrope Simple Models
• Experience with TOSCA, X‑Ray, and digital validation platforms such as Kneat
• Hands‑on experience with laboratory networking, infrastructure concepts, or instrument interfacing
• Prior commercial or QC lab experience
  
  

Core Competencies

• Strong analytical and problem solving skills
• Customer focused mindset and continuous improvement orientation
• Ability to communicate with clarity and influence diverse groups
• Adaptability in a rapidly evolving digital landscape
• High attention to quality, compliance, and documentation rigor
  
  

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Required Skills

Biochemistry, Chemistry, Commercial-Off-The-Shelf (COTS) Software, GMP Testing, Information Technology (IT), Laboratory Operations, Manufacturing, Microbiology, Pharmaceutical Quality Assurance, Software Development Life Cycle (SDLC)

Preferred Skills

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Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

04/12/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  
  

Requisition ID R392452