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

• Handson 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

• Excellent written verbal and visual communication skills with the ability to describe technical concepts to nontechnical stakeholders

• Ability to work both independently and collaboratively in a matrixed fastmoving 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 XRay and digital validation platforms such as Kneat

• Handson 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

Required Skills:

Preferred Skills:

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