• 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
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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
• 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

No Travel Required

• 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

Accountability, Accountability, Adaptability, Chemical Engineering, Clinical Pharmacy, Corrective Action Management, Customer-Focused, Data-Driven Decision Making, Data Integrity, Dosage Forms, Drug Product Development, Estimation and Planning, GMP Compliance, Innovation, Leadership, Lean Six Sigma (LSS), Manufacturing Engineering, Manufacturing Quality Control, Mechanical Engineering, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Product Formulation, Project Management {+ 5 more}

$126,500.00 - $199,100.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits