BioProcess Engineer II

Merz North America•Racine, WI

20h

About The Position

The BioProcess Engineer II leads the development, optimization, and support of manufacturing processes and equipment within a regulated medical device environment. This role manages process and equipment implementation projects, contributes to scale up efforts and continuous improvement activities, and supports production reliability across manufacturing operations. Responsibilities include process design, validation activities, troubleshooting, and collaboration with cross functional partners to ensure products and equipment meet performance, quality, and safety requirements, along with advancing ongoing efforts to refine and strengthen manufacturing processes. The engineer may also support automation initiatives involving robotics, vision systems, or controls programming. Success is measured through effective project execution, adherence to budgets and timelines, and contributions to long term manufacturing capability and reliability.

Requirements

Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science
3-5 years of engineering experience in manufacturing, product development, or process development within a regulated industry such as medical devices, pharmaceuticals, or similar.
Demonstrated experience supporting or leading process development activities, including verification, validation (IQ/OQ/PQ/PPQ), and technical documentation.
Hands-on experience troubleshooting and sustaining manufacturing equipment and production processes in a commercial manufacturing setting.
Experience contributing to or leading cross-functional engineering projects with defined timelines and deliverables.

Nice To Haves

Master of Science (M.S. or M.Sc.) Engineering, Business, or related discipline
Experience supporting automation related activities such as robotics integration, vision systems, or industrial controls.
Experience with PLC or HMI programming, or working with automation vendors or system integrators.
Experience executing or supporting process validation including IQ, OQ, PQ, and PPQ.
Experience developing or improving electromechanical or automated manufacturing processes.
Familiarity with ISO 13485, FDA QSR, GMP, or other regulated quality system requirements.
Experience managing external equipment suppliers, contractors, or integrators.
Ability to formulate program strategy, budgets and timelines
Understanding of process validation, and statistical analysis
Familiar with project management methods and tools
Solid works 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

Responsibilities

Process design and implementation: Lead the development and introduction of new manufacturing equipment and processes, including project scoping, budgeting, vendor engagement, and creation of required documentation such as qualification, verification, and validation protocols.
Process support and issue resolution: Identify and address production interruptions, perform root cause analysis, develop corrective and preventive actions, and determine calibration and maintenance needs for new and existing equipment to maintain stable and reliable manufacturing operations.
Process evaluation and optimization: Establish product and equipment specifications, develop standard operating procedures, assess production costs, and identify opportunities to improve efficiency, throughput, and overall process capability.
Project management: Create and maintain project timelines, manage budgets, and drive progress to meet departmental and organizational goals.
Cross functional support: Partner with production, quality, engineering, and supplier teams to support daily operations, technology transfer activities, and improvement initiatives.
Automation support: Assist in planning or executing automation activities by contributing to or owning projects involving robotics, vision systems, or controls where such technology supports process improvements or equipment upgrades.
General support: Provide engineering support as subject matter expert across departments as requested by stakehlders and management to contribute to a culture focused on safety, quality, and continuous improvement.