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Job Description
Structured overview of role & requirementsAbout This Role
Support installation, configuration, deployment, and maintenance of NuGenesis SDMS and Empower CDS laboratory systems within GMP-compliant manufacturing labs.
Manage system operations, integrations, validation activities (IQ/OQ/PQ), CAPA processes, and documentation to ensure regulatory compliance and data integrity.
Collaborate with senior analysts, lab teams, QA, and IT SMEs; contribute to automation, troubleshooting, and mentoring junior team members in lab systems engineering.
Minimum Requirements
15+ years experience in laboratory informatics or CDS/SDMS support, preferably pharma/biotech/chemicals industry.
Hands-on experience with NuGenesis SDMS and/or Empower CDS deployment and support in GMP-regulated environments.
Bachelor's degree in Computer Science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field.
Practical knowledge of GMP regulations including 21 CFR Part 11, Annex 11, ALCOA+ data integrity principles, and system validation (CSV/SDLC).
Ideal Candidate Profile
Experienced with lab systems integration focusing on scalability, maintenance, and automation within regulated manufacturing labs.
Proficient in managing CAPA processes, incident resolution, and compliance documentation in pharmaceutical GMP environments.
Comfortable collaborating across functional teams and mentoring junior engineers, with familiarity in lab informatics platforms and digital lab transformation projects.