Contract Manufacturing Engineer

Actalent•Kalamazoo, MI

63d•$40 - $45•Onsite

About The Position

The Contract Manufacturing Engineer will play a vital role in ensuring efficient and high-quality production processes. This position involves equipment qualification, process validations, and the setup and documentation of manufacturing processes. You will support three main production lines, helping them become operational for product manufacturing. The work will be evenly split between hands-on activities on the production floor and desk-based documentation tasks. This role is crucial in developing processes for an advanced wound care product, primarily focusing on mechanical processes.

Requirements

Bachelor's Degree in Engineering.
Experience in equipment qualification and process validation.
Experience in setting up new processes and Process Capability (Cpk).
Proficiency in engineering documentation, including Design of Experiments and SOP/work instructions.
Experience working within a structured QMS (ISO) or GMP or cGMP environment.
Minimum of 5+ years of relevant experience.

Nice To Haves

Experience with PFMEA.
Launch experience.

Responsibilities

Develop, implement, and continuously improve manufacturing equipment, processes, and systems to support efficient and high-quality production.
Ensure all production equipment and processes comply with Quality Management System (QMS) requirements, Standard Operating Procedures (SOPs), and applicable regulatory standards.
Design, implement, and optimize manufacturing systems and equipment for improved efficiency and reliability.
Support the design, testing, and validation of manufacturing systems and sub-systems.
Lead process qualification and production line validation activities.
Monitor process performance, identify areas for improvement, and implement solutions to enhance throughput and reduce waste.
Troubleshoot and resolve process or equipment issues through root cause analysis and corrective actions.
Collaborate with operations to maximize line utilization, material flow, and efficiency.
Support preventive maintenance and calibration activities to ensure equipment reliability and uptime.
Prepare clear and accurate technical documentation, reports, and work instructions.
Manage multiple open-ended projects requiring creative and analytical problem-solving skills.
Promote a culture of quality, continuous improvement, and professional integrity.