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Digital Transformation Project Lead

1 week ago

Copenhagen, Copenhagen, Denmark PQE Group Full time
About the Job

PQE Group is seeking a Laboratory Automation Specialist to support one of our clients in Copenhagen. The successful candidate will lead QC laboratory digitalization and automation projects, ensuring the successful implementation of LIMS, CDS, and other lab informatics solutions.

Key Responsibilities:
  • Manage end-to-end validation of computerized systems, including preparation of Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports, following GAMP 5 guidelines and CFR 21 Part 11 compliance.
  • Oversee the integration of laboratory systems (LIMS, CDS, ELN) with enterprise platforms, ensuring seamless data flow and compliance with Data Integrity principles.
Required Skills:
  • Degree in Chemistry, Engineering, Life Sciences, or related field
  • Proven experience (5+ years) in QC Automation, LIMS implementation, or CSV in pharmaceutical or biotech industries
  • Strong knowledge of GMP, GLP, GCP, CFR 21 Part 11, GAMP 5, and Data Integrity regulations