Digital Quality & Lab Instrument Senior Specialist

29

Competitive salary; incentive pyy available; benef...
Hybrid
5+ years sdlc experience for lab instrumentation
Deep knowledge of gmp environments and fda 21 cfr part 11
Hands-on experience with labx and client server applications
The role involves leading the technical implementation and sustainment of laboratory instruments across global labs while ensuring compliance with data integrity regulations

Job Summary

  • The role involves leading the technical implementation and sustainment of laboratory instruments across global labs while ensuring compliance with data integrity regulations.
  • Candidates will collaborate with cross-functional teams to define requirements, execute full SDLC deliverables, and drive efficiency in modern digital laboratories.
  • The company offers a hybrid working model, competitive salary with incentive pay, and extensive benefits including 5 weeks of annual leave and paid parental contributions.

Matching Summary

The role involves leading the technical implementation and sustainment of laboratory instruments across global labs while ensuring compliance with data integrity regulations.

Salary

Competitive salary; Incentive pay available; Benefits include pension, health contributions, and cafeteria tax-free options

Skills & Requirements

Must-have

  • 5+ years SDLC experience for lab instrumentation
  • Deep knowledge of GMP environments and FDA 21 CFR Part 11
  • Hands-on experience with LabX and client server applications
  • Expertise in Digital Validation Systems like Kneat eVal or TOSCA
  • Strong background in pharmaceutical quality and manufacturing operations

Nice-to-have

  • Experience with FAIR data principles and JSON schemas
  • Familiarity with instrument integration middleware like Scitara DLX
  • AWS Associate certification or cloud experience
  • Knowledge of Allotrope Ontologies and Simple Models
  • Prior commercial or QC lab experience

Key Requirements

  • Degree in life science, IT, or engineering discipline
  • Minimum 5 years of hands-on experience supporting robust testing strategies
  • In-depth knowledge of Data Integrity regulations (FDA 21 CFR Part 11, EU Annex 11)
  • VISA Sponsorship: Yes

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter