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Merz North America, Inc

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BioProcess Engineer II (Architecture)



About Us

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

Leads process development and equipment projects while maintaining schedules and meeting budgets. 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. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals.

 
What You Will Do
  • Process design: Manages 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.
  • Provide support within the Engineering department and other Merz departments as directed by Management.
Minimum Requirements

  • Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science.
  • 3-5 years of related design and manufacturing experience in the medical device and/or component industry.
Preferred Qualifications

  • Master of Science (M.S. or M.Sc.) Engineering, Business, or related discipline.
  • Process control experience including process verification and validation.
  • Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ).
Technical & Functional Skills

  • Ability to formulate program strategy, budgets and timelines.
  • Understanding of process validation, and statistical analysis.
  • Familiar with project management methods and tools.
  • Solidworks or other CAD experience.
  • Understanding and application of ISO Quality System requirements and FDA regulations.
  • Familiar with a variety of manufacturing processes including mechanical and electromechanical.
  • Practical knowledge of Six Sigma methodologies. Green or Black Belt certification.
  • Strong technical and problem-solving skills.
  • Ability to communicate and write effectively.
  • Emotional self-management in difficult situations.

Benefits:

  • 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!


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Process Engineering

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