Expert Science & Technology - Quality Control, Information Technology

Role Summary

Expert Science & Technology - Quality Control, Information Technology role located onsite in East Hanover, NJ. Responsible for supporting, maintaining, updating, and troubleshooting GMP analytical equipment for Cell and Gene Therapies, and leading system updates or enhancements within tight timelines in compliance with GxP requirements.

Responsibilities

• Acts as the SME for GxP lab systems for all analytical instruments in analytical labs (e.g., Flow cytometer, ddPCR, UPL, NGS, Empower).
• Ensure GxP lab systems comply with regulatory requirements (21 CFR Part 11, Annex 11).
• Manage day-to-day GxP lab systems/processes and support data integrity initiatives related to GxP lab systems.
• Collaborate with Analytical Development, Operations, IT, Engineering, and Validation to support lifecycle management from concept to retirement.
• Author, review, and approve corrective actions to protocols, investigations, non-conformances, CAPAs, and records related to GxP lab systems.
• Review and implement improvements to existing lab systems; develop SOPs and training related to GxP lab systems.
• Represent GxP lab systems in meetings; track follow-up items to completion.
• Plan and lead large GxP system projects (e.g., LIMS implementation, lab instrument qualification).
• Weekend support may be required in addition to Monday–Friday schedule.

Qualifications

• Required: Bachelor’s degree; degree in Biology, Biochemistry, Molecular Biology, Immunology, or related scientific discipline preferred.
• Required: Minimum of 3 years of industry experience in automation/digitalization projects in Pharmaceuticals.
• Required: Experience in instrument administration, preferably in CGT.
• Required: Strong knowledge of regulatory requirements and industry standards (GxP, FDA 21 CFR Part 11, EU Annex 11).
• Required: Experience with validation lifecycle documentation (URS, FRS, DS, IQ, OQ, PQ, traceability matrices).
• Required: Working knowledge of SQL, Java, or other LIMS programming language.
• Required: Experience in lifecycle management of GxP lab systems.

Education

• Bachelor’s degree required; preferred fields include Biology, Biochemistry, Molecular Biology, Immunology or related discipline.

Skills

• GxP compliance and regulatory understanding
• LIMS and lab system lifecycle management
• Data integrity and QA/QC practices
• Cross-functional collaboration and project leadership
• Analytical instrument knowledge (flow cytometry, ddPCR, UPL, NGS, Empower)