Job Description Summary

Provides leadership to project teams. Ensures that objectives for projects are met in terms of scope, time, cost, and quality.

Addresses technical, regulatory, business, and operational needs.

Enables a seamless transition to manufacturing and commercialization.

Coordinates efforts with cross-manufacturing and commercialization.

Coordinates efforts with cross-functional project team members to assure completion of programs in a manner that meets business, customer, and regulatory requirements.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Summary:
The Manufacturing Project Engineer will be responsible for leading and supporting capital projects across all manufacturing sites in BD Plymouth. This position collaborates with the Site Engineering Manager and will work closely with our Quality, Operations, Supply Chain, Maintenance, Finance, Safety and Environmental teams to ensure successful project execution. The role will also involve working with external suppliers on equipment installation and validation activities.

Responsibilities:

• Capital Project Management – Lead and support multiple concurrent capital projects focused on increasing capacity, improving quality, reducing cost/waste, or other key business drivers. Responsible for planning, executing, and closing out of projects within budgeted timeframe and financial constraints. Interact regularly with senior leadership to provide updates and obtain resources.
• Technical Support – Provide technical expertise and guidance throughout the product lifecycle (e.g., design, process development, commercialization, and post-commercialization). Collaborate with multi-functional teams including R&D, Operations, Process Development, and Regulatory Affairs as needed.
• Vendor Management – Work directly with external suppliers to lead the delivery of equipment, materials, and services related to capital projects. Develop strong relationships with vendors to drive value and innovation. Negotiate contracts and handle vendor performance to ensure accurate completion of results.
• Documentation and Reporting – Maintain accurate and complete documentation of project plans, status, issues, risks, and mitigation strategies. Generate regular progress reports and presentations for internal partners. Ensure compliance with GxP regulations and BD quality standards.
• Equipment Installation and Qualification – Coordinate the installation of new equipment and validation of existing equipment. Be responsible for the development of URS, FAT, IQ, OQ, and PQ protocols and reports. Collaborate with Validation Engineering to complete these studies according to established procedures.
• Continuous Improvement – Find opportunities for process improvements and cost reductions. Participate in Kaizen events and lead improvement projects as appropriate. Drive lean culture and continuous improvement attitude across the site.
• Training and Mentoring – Actively mentor and train junior engineers and technicians. Provide guidance and coaching to help team members develop their skills and advance their careers.
• Compliance and Safety – Adhere to all relevant regulatory requirements, safety guidelines, and Good Manufacturing Practices (GMP). Promote a safe work environment by identifying potential hazards and participating in risk assessments.
• Multi-functional Collaboration – Collaborate effectively with various departments, including Operations, Quality Assurance, Maintenance, Supply Chain, Finance, Safety, and Environmental. Build strong relationships and communicate clearly to achieve common goals.
• Change Control – Support the implementation of change controls, including Deviations, CAPAs, and Corrective Actions. Ensure that changes are properly evaluated, approved, and implemented in accordance with GxP regulations and BD policies.

Education and/ or Experience Required:

• Bachelor’s degree in Mechanical, Industrial, Chemical, or Biomedical Engineering required; Master’s degree preferred.