Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant

Role: Senior Engineer specializing in IT Laboratory and Quality Systems at Bristol Myers Squibb's Devens Biologics Digital Plant, supporting cGMP compliance and digital lab operations. Responsibilities: manage documentation, benchtop equipment, and quality systems security; oversee system reliability assessments; act as plant SME; ensure data integrity, application configuration, and cybersecurity meet regulatory standards; support audits and inspections; identify technology efficiencies; develop validation methodologies; support compliance with industry and BMS directives. Requirements: Bachelor's in Mechanical or Computer Engineering or related field; 5+ years in Validation Engineering or similar roles in biotech/pharma; experience with Lean/OpEx methodologies, LIMS, LES, ELN, document systems, Waters NuGenesis, Empower; knowledge of SOPs, GxP, FDA/EU regulations; proficiency in IT/network concepts, databases, servers, user management; regulatory audit support experience. Preferred: familiarity with industry validation standards and digital manufacturing. HighValue: biologics manufacturing, digital lab systems, cGMP, regulatory audits, validation, biotech/pharma compliance. WorkSetup: hybrid in Devens, MA; up to 20% domestic travel.