Manufacturing Engineer

Manufacturing Engineer

This Manufacturing Engineer role focuses on supporting and optimizing automated pharmaceutical production lines in a highly regulated, state-of-the-art manufacturing environment. You will analyze equipment and process capacity, lead the implementation of new manufacturing lines, and drive continuous improvement initiatives to enhance efficiency, yield, and reliability. The position offers the opportunity to become the subject matter expert for advanced automated equipment while collaborating closely with cross-functional stakeholders and vendors.

Responsibilities

• Analyze equipment and process capacity constraints to identify bottlenecks and develop technical solutions that increase capacity, reduce equipment downtime, and improve efficiencies and yield.
• Qualify and implement new manufacturing lines, including planning, coordination, and execution of equipment installation, startup, and validation activities.
• Serve as the subject matter expert for automated manufacturing equipment once the new line is implemented, providing technical leadership and guidance.
• Monitor production processes and collect, analyze, and interpret data from production equipment to identify and implement continuous improvement opportunities.
• Support and troubleshoot automated manufacturing and robotics equipment on the production floor, working hands-on with machinery and collaborating with technicians.
• Manage projects from concept through qualification, purchase, implementation, and optimization, ensuring timelines, budgets, and quality standards are met.
• Collaborate with process engineers, technology managers, capital engineers, and other stakeholders to align equipment capabilities with production and business needs.
• Oversee documentation review related to equipment, processes, and quality requirements, ensuring compliance with Good Manufacturing Practices (GMP).
• Participate in equipment maintenance planning and support efforts to maintain high levels of equipment reliability and performance.
• Travel approximately once per month during the initial months of the role to vendor sites, primarily within the United States, to test and evaluate machinery prior to purchase and implementation.
• Contribute to capital projects by supporting equipment selection, installation, startup, and optimization activities in a regulated manufacturing environment.
• Engage with vendors and suppliers to evaluate equipment performance, negotiate technical requirements, and ensure successful integration into existing production processes.

Essential Skills

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related discipline.
• 2–7+ years of experience supporting manufacturing equipment and production operations.
• Experience with automated manufacturing equipment, robotics, or pick-and-place systems.
• Experience troubleshooting production equipment in a manufacturing environment.
• Experience leading projects from concept through implementation.
• Strong project management and organizational skills.
• Ability to communicate effectively with multiple stakeholders at different levels of the organization.
• Comfort working directly on the production floor and interacting with technicians.
• Experience working in a GMP-regulated manufacturing environment.
• Pharmaceutical manufacturing experience or experience in a similar regulated industry such as medical device, consumer products, or food manufacturing.

Additional Skills & Qualifications

• Experience in manufacturing engineering, including exposure to automation, robotics, and mechanical engineering applications.
• Exp. in quality inspection and documentation review within a regulated environment.
• Experience with equipment maintenance and support for production machinery.
• Familiarity with manufacturing processes in pharmaceutical, medical device, consumer products, food, or other regulated industries.
• Equipment qualification and validation experience, particularly in GMP environments.
• Experience with packaging equipment in a regulated manufacturing setting.
• Experience with equipment selection, installation, and startup activities.
• Capital project experience, including coordination with project engineering and capital engineering teams.
• Vendor and supplier management experience, including equipment evaluation and acceptance testing.
• Exposure to production processes involving automated systems, robotics, and pick-and-place technologies.
• Ability to work effectively in a team environment and collaborate across engineering, operations, and quality functions.

Work Environment

The role is based in a clean, state-of-the-art pharmaceutical manufacturing facility that includes a mix of office space, laboratories, and production areas. You will spend significant time on the production floor working directly with automated manufacturing equipment and interacting with technicians and engineering staff. The environment operates under strict Good Manufacturing Practice (GMP) standards, with a strong focus on…