Demo

Mechanical Engineer

CONTINUUS Pharmaceuticals
Woburn, MA Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/7/2025

CONTINUUS Pharmaceuticals is disrupting the pharmaceutical manufacturing industry with our Integrated Continuous Manufacturing (ICM) process. We have an immediate need for a junior (Associate or Engineer I level) Mechanical Engineer to join our team. Our Mechanical Engineers design and develop novel continuous pharmaceutical production unit operations (filter, dryer, extrusion injection molding) that are essential machines for the ICM process. In this role, you will be responsible for implementing a cutting-edge continuous manufacturing technology platform (Extrusion-Molding) used to produce small-molecule APIs in OSD.

Key responsibilities :

  • Maintenance and troubleshooting of Extrusion-Molding machine
  • Support Extrusion-Molding operation
  • Ownership and SME of the Extrusion-Molding machinery
  • Continuous improvement on the EMC machine
  • Design modification support and vendor communication
  • Engineering support on the commercial system of extrusion-Molding machine
  • Perform engineering calculations to support design work
  • Create and review technical drawings, plans, and specifications.
  • Perform detailed documentation to track project development and the design process.
  • Monitor equipment through regular testing.
  • Perform calculations / analytical analysis of machines in support of achieving product performance requirements
  • 2D drawings with GD&T
  • Performs risk analyses using FMEA
  • Full understanding of machine process including welding, machining, surface finishing, and plastic molding
  • Work with suppliers, machinists, and contract manufacturers to design novel pharmaceutical machines
  • Develop technical specifications (e.g., equipment specifications, facility layouts, engineering documents)
  • Coordinate across multiple internal disciplines (e.g., process, automation, mechanical, development) as well as external resources to develop engineering specifications.
  • Ensure compliance with both internal and external protocols and regulations.
  • Run risk assessments of the equipment and processes being used.
  • Utilize experience and knowledge in a creative way to implement novel continuous pharmaceutical processing technologies in a commercial setting.

Other responsibilities :

  • Contribute to and author project reports, peer-review journal publications, and participate in meetings / conferences.
  • Design appropriate plans to meet project goals, timelines and budget.
  • Work closely and collaboratively with interdisciplinary teams.
  • Occasionally asked to perform duties beyond formal job responsibilities.
  • Educational requirements :

  • Bachelor's or Master’s degree in Mechanical Engineering
  • Experience and skill requirements :

  • 0-2 yrs engineering experience in pharmaceutical manufacturing industry, preferred.
  • Firm grasp of engineering concepts, and experience designing mechanical systems and products.
  • Preferred - Experience designing pharmaceutical processing equipment for cGMP environments.
  • Experience using CAD software (SolidWorks preferred).
  • Ability to write clear and comprehensive technical documentation.
  • Preferred - Ability to read P&IDs and other process documentation.
  • Hands-on experience with process equipment.
  • Understanding of fundamental engineering principles and the engineering lifecycle related to process design through implementation (e.g., installation, validation, change control, and continuous improvement).
  • Preferred - Experience with pilot scale process equipment and pharmaceutical process R&D.
  • Preferred - Experience with handling compressed air, vacuum, and heat transfer equipment.
  • Preferred - Experience with developing and executing Commissioning, Equipment Qualifications and Performance Qualification documents.
  • Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines.
  • Excellent written and verbal communications skills
  • Ability to work well in cross-functional teams
  • Microsoft Office suite experience (Outlook, Teams, Word, Excel, PowerPoint)
  • CONTINUUS is an equal opportunity employer offering a competitive compensation and benefit package.

    Notice to Recruiting Agencies : CONTINUUS is not using a recruiting agency to fill this role. There is no need to reach out regarding candidates in your portfolio.

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