✦ Luna Orbit — Science & Research

Specialist, Engineer I, MSAT Process Engineering

at Bristol-Myers Squibb

📍 Summit West - NJ - US Hybrid 💰 $68K – $83K USD / year Posted March 13, 2026
Salary $68K – $83K USD / year
Type Full-Time
Experience entry
Exp. Years 0+ years
Education Not specified
Category Science & Research

This role supports the production of personalized cell therapy products by providing manufacturing support, investigating deviations, and maintaining documentation to ensure quality and compliance.

  • Provide process support
  • Support deviation investigations
  • Maintain batch records
  • Assist in inspections
  • Support process monitoring

The position involves working with cGMP standards, SOPs, batch records, and validation documentation within a biopharmaceutical manufacturing environment, particularly in cell therapy production.

The ideal candidate is an entry-level process support specialist with a basic understanding of cGMP and manufacturing documentation in cell therapy or biopharmaceutical environments. They should have strong attention to detail and problem-solving skills to support manufacturing investigations and documentation.

support manufacturing activitiesinvestigation supportdocumentation creation/revisionunderstanding of cGMP requirementssupport health authority inspections
experience with CAR-T manufacturingexperience with validation activitiesexperience with deviation investigations
Electronic Batch RecordsMBRsvalidation documentation tools
cGMPSOPvalidation documentationroot cause analysisManufacturing Batch RecordsMBRsprocess supportinvestigationsprocess monitoringtechnical reports
cGMPSOPvalidation documentationroot cause analysisManufacturing Batch RecordsMBRsProcess SupportManufacturing InvestigationsProcess MonitoringTechnical Reports
collaborationcommunicationproblem-solvingattention to detailteamwork
Industry Healthcare & Medical
Job Function Manufacturing support and quality documentation in cell therapy production
Process SupportManufacturing InvestigationsRoot Cause AnalysiscGMPSOPValidation DocumentationBatch RecordsMBRsDeviationsTechnical ReportsManufacturingCell TherapyQuality AssuranceRegulatory ComplianceGMPManufacturing SupportValidation

Lack of experience with manufacturing documentation, No understanding of cGMP requirements, Unwillingness to work in a hybrid environment, No experience with validation activities

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