Digital Quality & Lab Instrument Senior Specialist

539

Competitive salary; incentive pyy included; not sp...
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5+ years sdlc experience in gmp environments
Deep knowledge of fda 21 cfr part 11 and eu annex 11
Hands-on experience with labx and cots standalone systems
** The position of Digital Quality & Lab Instrument Senior Specialist focuses on the implementation and management of analytical instruments within a digital validation framework at a global pharmaceutical company. Ideal candidates will possess a strong background in life sciences or IT, with hands-on experience in laboratory systems and compliance with regulatory standards. **

Job Summary

  • The role involves leading the technical implementation and sustainment of global laboratory instrumentation systems within a digital validation framework.
  • Candidates must ensure compliance with strict data integrity regulations including FDA 21 CFR Part 11 while collaborating across functional boundaries.
  • The company offers a hybrid working model, competitive salary with incentive pay, and extensive benefits including 5 weeks annual leave and paid parental contributions.

Matching Summary

Match Score: 75

** The position of Digital Quality & Lab Instrument Senior Specialist focuses on the implementation and management of analytical instruments within a digital validation framework at a global pharmaceutical company. Ideal candidates will possess a strong background in life sciences or IT, with hands-on experience in laboratory systems and compliance with regulatory standards. **

Salary

Competitive salary; Incentive pay included; Not specified

Skills & Requirements

Must-have

  • 5+ years SDLC experience in GMP environments
  • Deep knowledge of FDA 21 CFR Part 11 and EU Annex 11
  • Hands-on experience with LabX and COTS standalone systems
  • Proficiency with digital validation tools like Kneat eVal or TOSCA
  • Strong background in pharmaceutical quality and lab 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 hands-on experience with SDLC deliverables
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter