BioProcess Engineer

Merz Pharmaceuticals USA•Franksville, WI

45d

About The Position

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. A Brief Overview 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.

Requirements

Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science.
Less than 1 year of relevant work experience.
Familiar 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.

Nice To Haves

Master of Science (M.S. or M.Sc.) in Engineering, Business, or related discipline.
3+ years of medical device or pharmaceutical process experience or similar experience in a regulated industry.

Responsibilities

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 Identify production interruptions and establish risk mitigations. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment.
Process evaluation Establish new product costs, develop and implement necessary SOP's, and establish processing, packaging and test specifications for products and equipment. Identify process inefficiencies and implement strategies, including automation and scale-up, to identified areas.
Maintain Budgets Create and maintain project time lines and plans, accelerating where possible. Create project and/or capital budgets in cooperation with management to meet department budgets.