Specialist, Engineering (Onsite)

Role: Non-Sterile Specialist in Engineering supporting formulation and filling operations at the Rahway, NJ FLEx facility, primarily during second shift. Objectives: maintain GMP/compliant facilities and equipment to ensure timely clinical and developmental batch production for oral solid dosage (OSD) products. Responsibilities: troubleshoot and support equipment and utilities, manage validation activities, oversee change control, investigate deviations, maintain GMP documentation, support equipment commissioning, and serve as a technical SME during operations. Qualifications: Bachelor’s in engineering with at least 2 years supporting pharmaceutical manufacturing of OSD formats; familiarity with cGMP, quality systems, and OSD equipment; experience with CMMS, troubleshooting (mechanical/electrical/automation), and process validation. Preferred: expertise in maintenance management, SAP Plant Maintenance, electronic validation systems (eVal/Kneat), calibration systems (ProCal), and project management. HighValue: supporting formulation/operation of clinical/stability supplies, GMP compliance, process optimization, validation, and utilities management within a pharma manufacturing environment. Collaboration: partners with GES, Facilities Management, OEMs, vendors, and clinical operations. Work setup: on-site, second shift (evening), with approximately 10% travel.