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Merck · 2 days ago

Associate Director, Engineering (Onsite)

Rahway, NJ

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$126K/yr - $199K/yr

8+ years exp

Merck is a leading pharmaceutical company seeking an Associate Director of Engineering to support specialty dosage forms and oral solid dosage GMP development activities. The role involves serving as the technical lead for shift production, ensuring safety, quality, and compliance while coaching and developing the shift team.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

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

Qualification

GMP ComplianceManufacturing EngineeringProcess EngineeringData IntegrityRoot-Cause AnalysisLean Six SigmaMechanical EngineeringChemical EngineeringPharmaceutical Process DevelopmentAccountabilityInnovationLeadershipAdaptabilityCustomer-Focused

Required

Bachelor's degree in Engineering or Science (e.g., Mechanical, Chemical, Biomedical) or equivalent GMP manufacturing experience

8+ 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