BioProcess Engineer

Process Development Engineer

Contributes to equipment projects and manufacturing process improvements. Provides insight and contributes to production reliability. Participates as a team member for technical operations sections of product development projects, including scale-up and production line design. Leads process development and equipment projects while maintaining schedules and meeting budgets. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals.

Process design coordinates implementation of manufacturing equipment, process automation, process expansions, and new initiatives. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.

Process sustenance identifies production interruptions and establishes risk mitigations. Troubleshoots equipment and processing issues in support of production goals. Determines calibration and maintenance needs of new equipment.

Process evaluation establishes new product costs, develops and implements necessary SOP's, and establishes processing, packaging, and test specifications for products and equipment. Identifies process inefficiencies and implements strategies, including automation and scale-up, to identified areas.

Maintains budgets creates and maintains project timelines and plans, accelerating where possible. Creates project and / or capital budgets in cooperation with management to meet department budgets.

Minimum requirements include a Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science. Less than 1 year of relevant work experience is required.

Preferred qualifications include a Master of Science (M.S. or M.Sc.) in Engineering, Business, or related discipline. Three or more years of medical device or pharmaceutical process experience or similar experience in a regulated industry is preferred.

Technical and functional skills include familiarity with ISO 13485 / FDA QSR / GMP / Other medical industry regulations. Ability to formulate program strategy, budgets, and timelines. Solidworks and / or AutoCAD. Six Sigma Methodologies. Statistical Analysis. Strong technical and problem-solving skills. Ability to communicate and write effectively.

Benefits include comprehensive medical, dental, and vision plans, 20 days of paid time off, 15 paid holidays, paid sick leave, paid parental leave, 401(k), employee bonuses, and more! Your benefits and PTO start the date you're hired with no waiting period!

Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.