Sr. Specialist, Engineering (Onsite)
Merck · Rahway, NJ
Manufacturing OperationsFull-time$117k–$184kCompany career page
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Role summary
Merck seeks a Senior Specialist in Engineering to lead operational readiness for the FLEx Sterile Expansion Project in Rahway, New Jersey. The role involves sterile drug product manufacturing facility design, commissioning, qualification, and startup for a new clinical supply cGMP facility handling small molecules, biologics, vaccines, and antibody-drug conjugates.
What they're looking for
- Bachelor's degree in Engineering, Science, or Operations Management with 5+ years relevant experience
- Master's degree with 3+ years relevant manufacturing or GMP experience
- Sterile drug product manufacturing expertise with aseptic technique and GMP/clinical supply operations knowledge
- Equipment operation, setup, and troubleshooting skills including robotics and automated systems
- Strong documentation abilities including SOP preparation and GxP compliance experience
- Proficiency with data analysis tools such as Excel, Minitab, Power BI, and R Shiny
- Experience with new GMP facility startup and Lean continuous improvement principles
What you'll be doing
- Lead operational readiness workstreams for facility expansion including equipment design and system commissioning
- Operate aseptic formulation, filling, and lyophilization equipment and perform Grade A barrier isolation manipulations
- Develop and maintain SOPs, work instructions, batch records, and training curricula for startup readiness
- Lead digital tool implementation and training programs for process insights and predictive analytics
- Conduct readiness assessments, dry runs, and simulations to ensure personnel and processes are prepared for GMP manufacturing
Privacy & handoff
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