Events

• Support microbiological and aseptic process impact assessments for internal manufacturing investigations, including environmental monitoring excursions, bioburden failures, sterility test failures, and aseptic process deviations
• Evaluate root cause analyses and contribute to product, process, and patient impact assessments under senior scientist guidance
• Author and contribute to impact assessment documentation, deviation records, and CAPA reviews
• Track action items and CAPA effectiveness with site Investigation Leads
• Monitor and trend microbiological data to identify contamination signals and systemic issues
• Collaborate with Microbiology, Quality, MS&T, Manufacturing, and Validation teams
• Prepare documentation and provide technical input for regulatory inspections and internal audits
• Review and assess sterility and microbiological investigation impact assessments from external manufacturing partners
• Provide technical input on external manufacturing assessment quality and root cause adequacy, escalating risks and gaps
• Support quality risk assessments and periodic risk reviews at CMOs/CDMOs
• Participate in remote or on-site technical interactions with external manufacturing partners
• Support environmental monitoring program reviews, cleanroom classification, and gowning qualification
• Contribute to contamination control strategy development and maintenance aligned with EU GMP Annex 1 and ICH Q9
• Support aseptic process change control reviews and cGMP improvements
• Develop and maintain SOPs, guidance documents, and training materials
• Stay current with regulatory guidance and share learnings
• Participate in cross-functional projects, working groups, and sterility assurance and microbiology forums
• Develop technical expertise in aseptic manufacturing, contamination control, and investigation methodology

Manager, Contamination Events – Sterility Assurance Support

• Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events
• Serve as the MQSA SME for microbiological and aseptic process impact assessments
• Evaluate root cause analyses and assess product, process, and patient impact
• Review and formally sign off on impact assessments, investigation reports, CAPA records, and deviation documentation
• Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness address microbiological and aseptic process risk
• Lead rapid containment and triage for sterility breaches, leaks, mold recoveries, and contamination events
• Track and trend impact assessment outcomes to identify systemic issues and emerging risks
• Support regulatory agency inspections and audits related to impact assessment findings and sterility assurance
• Serve as technical liaison for External Manufacturing partners on sterility and microbiological investigations
• Review ExM impact assessments and investigation reports and provide feedback on risk evaluation and CAPA responses
• Support CMO quality risk assessments and periodic reviews of aseptic processing, contamination control, and microbiological data trends
• Design and implement standardized CMO oversight tools, dashboards, and decision trees
• Participate in remote and on-site technical reviews with CMOs during escalated events or regulatory commitments
• Participate in CMO site assessments and vendor selection; serve as technical SME on External Manufacturing quality audit teams
• Provide expertise on barrier technology, cleanroom design, gowning programs, and aseptic technique qualification
• Support aseptic process simulations/media fills, process validation, and revalidation activities
• Contribute to contamination control strategies aligned with EU GMP Annex 1 (2022)
• Review aseptic process change controls and provide risk-based SME input
• Support cGMP improvements and regulatory guidance interpretation
• Consult on microbial sampling during technology transfers and qualification activities
• Author and approve CMC documents for process validation P.3.5 sections
• Support CMC queries and resolutions with Global Health Authorities and support plant inspections
• Mentor site-level microbiologists and quality professionals
• Contribute to global MQSA standards, SOPs, guidance documents, and training materials
• Monitor industry trends, regulatory updates, and scientific literature
• Represent MQSA in cross-functional teams, steering committees, and governance forums
• Interface with BPOG, ISPE, and PDA industry consortiums

Events jobs in New Jersey

Manager, Contamination Events – Sterility Assurance Support

Senior Manager, Contamination Events and Investigations