Process Development Engineer, Device and Packaging Development

About the role

The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Process Development Engineer to join our team and contribute to our success in meeting the needs of our business and our patients.

Responsibilities

• Contribute to the development of fill finish and device assembly processes for sterile drug products and drug-device combination products, supporting clinical introduction and commercial launch.
• Collaborate with Clinical and Commercial Manufacturing to develop robust fill-finish and device assembly processes for new products, from early device and combination product development through prototyping, scale up, clinical, and commercialization.
• Participate in design for manufacturing (DFM) activities and process assessments to identify fits/gaps for new products, recommend manufacturing-process strategy, and support manufacturing site selection activities as needed.
• Participate in Design Reviews to ensure design robustness and manufacturability.
• Support knowledge transfer into internal and external manufacturing sites (CMOs) — including component specifications, test methods, equipment specifications, vendor / equipment selection, vendor management, factory acceptance testing (FAT), and qualification — and assist in the development and execution of IQ/OQ/PQ as well as process validations for combination products in accordance with established regulations, corporate policies and procedures.
• Provide technical support to manufacturing sites in close partnership with Clinical and Commercial Manufacturing to sustain product and process robustness and improve equipment performance, productivity, and asset utilization, including ongoing process performance metrics where applicable.
• Support product or process improvement and optimization at internal and external sites utilizing Lean and Six Sigma methodologies and support process risk assessment activities to identify critical process parameters and develop control plans to mitigate risks.
• Evaluate post design transfer changes (component, product, process) for impact on the manufacturing process, documentation, and design control elements, working with the manufacturing site, R&D, and Quality to assess risk/impact based on Design History File and in accordance with Design Controls.

Requirements

• Minimum Bachelor of Science/Engineering in Mechanical, Biomedical, Industrial Engineering, or relevant engineering discipline.
• Advanced Degree (MS/M Eng) preferred.
• Minimum 5 years’ work experience in a regulated industry with a Bachelor’s degree, 2+ years with an advanced degree.
• Process development and engineering experience in the Medical Device, sterile drug products, Pharmaceutical or Biotechnology industry, with experience in aseptic processing (including filling), device assembly, labeling, molded plastic components and automated inspection.
• Ability to travel domestically and internationally, up to 15%.
• Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus.
• Demonstrated ability to Influence areas not under direct control to achieve objectives.
• Work in a matrix environment and effectively support internal & external manufacturers and suppliers.
• Apply disciplined process development methods aligned with design controls, technology transfer, and validation principles for device and combination products.
• Strong technical, analytical and skills, as well as strong mechanical aptitude.
• Apply strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
• Communicate effectively, including internal/external presentations to suppliers, sites, and Sr. Management.

Qualifications

• Minimum Bachelor of Science/Engineering in Mechanical, Biomedical, Industrial Engineering, or relevant engineering discipline.
• Advanced Degree (MS/M Eng) preferred.
• Minimum 5 years’ work experience in a regulated industry with a Bachelor’s degree, 2+ years with an advanced degree.
• Process development and engineering experience in the Medical Device, sterile drug products, Pharmaceutical or Biotechnology industry, with experience in aseptic processing (including filling), device assembly, labeling, molded plastic components and automated inspection.
• Ability to travel domestically and internationally, up to 15%.
• Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus.
• Demonstrated ability to Influence areas not under direct control to achieve objectives.
• Work in a matrix environment and effectively support internal & external manufacturers and suppliers.
• Apply disciplined process development methods aligned with design controls, technology transfer, and validation principles for device and combination products.
• Strong technical, analytical and skills, as well as strong mechanical aptitude.
• Apply strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
• Communicate effectively, including internal/external presentations to suppliers, sites, and Sr. Management.

Skills

• Process development and engineering experience in the Medical Device, sterile drug products, Pharmaceutical or Biotechnology industry, with experience in aseptic processing (including filling), device assembly, labeling, molded plastic components and automated inspection.
• Ability to apply Lean and Six Sigma methodologies to process and product improvement.
• Strong technical, analytical and skills, as well as strong mechanical aptitude.
• Strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions.
• Effective communication skills, including internal/external presentations to suppliers, sites, and Sr. Management.

Benefits

Read more careers.bms.com/working-with-us.

Pay

New Brunswick - NJ - US $96,290 - $116,678

Schedule

US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays