Specialist, Engineering

Role: Process/Facility Engineer supporting the development and startup of a new potent, multi-modality Drug Substance GMP manufacturing facility in Rahway, NJ, within the MACS Operations team. Responsibilities: contribute to equipment and facility design, system commissioning/qualification, support process development, process validation, GMP documentation, and facility operations. Engage with cross-functional stakeholders including Process R&D, Analytical, Quality, and Safety to ensure quality, compliance, and efficiency of clinical manufacturing. Qualifications: Bachelor's degree in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Sciences with 3+ years of GMP experience, including GMP facility design, equipment startup, and process development for small and/or large molecules. Skills: GMP compliance, process hazard analysis, SOP preparation, troubleshooting, and cGMP documentation. Preferred: experience with pilot plant operations, potent compound processing, process hazard analysis, automation systems (DeltaV, PLC), and utility systems management. High-Value: involvement in GMP clinical supply, process scale-up, and multi-modality drug development including small molecules, macrocyclic peptides, and bioconjugates. Work setup: On-site at Rahway, with approximately 10% travel.