Senior Specialist, Manufacturing Engineer; Onsite

Position: Senior Specialist, Manufacturing Engineer (Onsite)
** 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).
* Lead room readiness and equipment readiness: plan/execute room setup; equipment assembly/disassembly; cleaning; line clearance; changeover.
* Author, execute, and close GMP documentation (batch records, logs, investigations, CAPA, change controls); ensure data integrity in MES (e.g., PAS‑X) and ALCOA principles.
* Troubleshoot equipment/system issues and drive root‑cause analysis with peer specialists, formulation scientists, facility engineers, and automation engineers; implement robust corrections/preventive actions.
* Coach and develop the shift team by actively sharing knowledge, standardizing best practices, and identifying improvements that strengthen safety, quality, delivery, and cost.
* Lead improvement activities on one of the specialty equipment trains in the oral solid dosage facility
* Champion Ways of Working and continuous improvement; lead small projects from scoping through qualification and handover.
* Approves equipment disposition (repair, replace, optimize) based on condition, reliability, and product requirements; coordinates with Maintenance/Facilities, Automation, production, process engineering and formulators.
** Minimum Qualifications
*** Bachelor’s degree in Engineering or Science (e.g., Mechanical, Chemical, Biomedical) or equivalent GMP manufacturing experience.
* 5+ years in GMP clinical or commercial manufacturing (OSD or specialty dosage forms) with hands‑on equipment setup, cleaning, and troubleshooting.
* Demonstrated knowledge of cGMP, data integrity, batch documentation, investigations, and CAPA.
* Experience with OCT, FCT and encapsulation manufacturing; spray dryers, autoinjector assemblies, isolators (OEB4/OEB5), or comparable specialty equipment.
* Strong problem solving and root‑cause analysis skills; ability to lead and train operators/technicians on the floor.
* Ability to work second shift on‑site in classified GMP suites.
** Preferred Qualifications
*** MES experience (e.g., PAS‑X) and proficiency with electronic logbooks and quality systems.
* Exposure to potent compound handling and containment strategies; respirator/gowning certification a plus.
* Lean/Six Sigma certification or practical application; familiarity with TPM/RCM and basic reliability tools.
* Working knowledge of EHS risk assessment (JSA/WRAs) and equipment qualification/validation basics.#PSCS#eligibleforERP
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* Required Skills:

** Accountability, Accountability, Adaptability, Analytical Testing, Automation, Clinical Pharmacy, Corrective Action Management, Data Analysis, Data Integrity, Detail-Oriented, Deviation Management, Dosage Forms, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Lean Six Sigma (LSS), Manufacturing, Manufacturing Engineering, Mechanical Engineering, Process Design, Process Engineering, Process Hazard Analysis (PHA), Process Optimization, Project Management, Quality Management {+ 5 more}
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers…