Senior Manufacturing Engineer
We are partnering with an established manufacturer in the Rochester area seeking a Senior Manufacturing Engineer to support manufacturing operations within a highly regulated production environment. This role serves as a technical leader responsible for optimizing manufacturing processes, implementing new equipment, supporting new product introductions, and driving continuous improvement initiatives that enhance safety, quality, efficiency, and Overall Equipment Effectiveness (OEE).
The Senior Manufacturing Engineer serves as a subject matter expert (SME) for filling and packaging systems and provides technical leadership across engineering projects involving manufacturing systems, non-sterile filling systems, packaging equipment, process pumps and piping, utility systems, facility upgrades, and associated control systems.
Working closely with Engineering, Quality, Compliance, Product Development, Operations, Supply Chain, and Business Development, this individual will evaluate manufacturing requirements, recommend technical solutions, and lead projects from concept through successful production implementation.
Responsibilities
· Serve as the technical subject matter expert (SME) for manufacturing, filling, and packaging systems.
· Lead the optimization of existing manufacturing and packaging lines through equipment upgrades, process improvements, and internal design enhancements.
· Lead the specification, purchase, installation, commissioning, validation, and optimization of fully integrated manufacturing and packaging equipment.
· Engage in technical discussions with equipment manufacturers and suppliers to develop solutions, review designs, evaluate proposals, and support equipment procurement.
· Partner with Product Development and customers to troubleshoot manufacturing challenges and identify equipment or process solutions that support new products.
· Collaborate with Quality, Compliance, Product Development, and Business Development to assess new customer requirements and develop manufacturing solutions that support successful product launches.
· Perform engineering risk assessments and independently manage projects from concept through production startup, including project planning, scheduling, milestone management, and execution.
· Coordinate with Supply Chain and Production Scheduling to secure manufacturing line availability, execute equipment trials, collect critical process parameters, and document project outcomes.
· Assist with equipment commissioning activities and support the successful transition of new equipment into production.
· Participate in domestic and international Factory Acceptance Testing (FAT) activities with equipment suppliers.
· Develop operating procedures, work instructions, and training materials while ensuring a successful transfer of equipment and process ownership from Engineering to Operations.
· Deliver technical training to production personnel and simplify complex manufacturing processes into effective operational practices.
· Benchmark emerging technologies and evaluate equipment retrofits and process improvements that increase productivity, product quality, yield, and Overall Equipment Effectiveness (OEE).]
Qualifications
· Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
· 8+ years of manufacturing engineering experience within a regulated manufacturing environment.
· Experience supporting pharmaceutical, medical device, food & beverage, or other highly regulated manufacturing operations.
· Demonstrated experience leading capital equipment projects from concept through commissioning and production startup.
· Proficiency with CAD software and P&ID creation, editing, and review.
· Detailed knowledge of filling and packaging equipment, automated manufacturing systems, machine vision systems, and equipment validation requirements a plus.
· Experience working with process pumps, piping systems, utility systems, and manufacturing infrastructure projects a plus.
· Proficient knowledge of pharmaceutical cGMP requirements and regulated manufacturing systems is highly preferred.
Pay: $90,000.00 - $115,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
