Sr. Specialist, Engineering (Onsite)

Job description

Job Description The Rahway FLEx (Formulation Laboratory & Experimentation) Center is a flexible, agile facility that brings together capabilities, operations, and talent to accelerate the pipeline— Pharmaceutical Operations & Clinical Supply is seeking applicants for a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage (OSD) GMP development activities on second shift. The successful incumbent will serve as the technical lead for shift production, coordinating safety, quality, and equipment decisions. This role evaluates safety, product/process quality, and equipment performance and determines the appropriate path forward to protect patients, people, and compliance. Key Responsibilities: Own technical decisions for the shift and act as the primary production engineering point of contact for Non‑Sterile operations. Evaluate safety, quality, and equipment status; make real‑time technical determinations on next steps, including stop‑work when risk warrants; escalate and document per cGMP expectations. Serve as owner and trainer for key equipment with emphasis on specialty setups (e.g., spray drying, autoinjector assembly, potent‑processing isolators)...