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Tier-1 brand, metro location, and mid-level experience increase applicant density, but niche lab-informatics skills limit competition.
Requires GMP-regulated lab CDS/SDMS expertise, making candidate background fit highly domain-specific.
Explicit 3-year minimum plus mandatory NuGenesis/Empower, GMP, and validation requirements make shortlisting highly strict.
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Support installation, configuration, and maintenance of NuGenesis SDMS and Empower CDS lab systems, including integrations and ensuring GMP compliance.
Coordinate and execute system validation activities (IQ/OQ/PQ), incident resolution, and CAPA processes within regulated laboratory environments.
Collaborate with cross-functional teams to optimize laboratory operations through digital initiatives and maintain related documentation and SOPs.
Bachelor's degree in Computer Science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field.
Minimum 3 years of experience in laboratory informatics or CDS/SDMS support in pharmaceutical, biotech, or chemical industries.
Hands-on experience with NuGenesis SDMS and/or Empower CDS deployment and support in GMP-regulated environments.
Practical knowledge of GMP regulations including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles; experience with system validation, incident handling, and CAPA processes.
Experienced in laboratory informatics systems support with focus on NuGenesis SDMS and Empower CDS platforms.
Comfortable working in regulated environments with strong understanding of compliance, validation, and data integrity requirements.
Able to operate within defined global governance frameworks and collaborate with multi-disciplinary teams to maintain system operations and documentation.