Manager, Manufacturing Process Engineer

The Role

In this role, you will lead a team of process engineers who are responsible for supporting the day-to-day operations of our cutting-edge manufacturing processes at Norwood, while also being directly involved in the hands-on aspects of team. This role will be instrumental in optimizing and innovating manufacturing processes to ensure efficient, high-quality production. It will focus on overseeing the development, implementation and enhancement of equipment related processes, providing strategic direction, and driving continuous improvement initiatives to our growing, fast-paced, multiproduct environment.

Here’s What You’ll Do

• Manage and guide a team of process engineers setting clear objectives and providing guidance regarding their day-to-day tasks, and short-term projects.

• Provide direct engineering support for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc…) to reduce manufacturing events, user interventions and batch record alerts.

• Serve as a senior technical specialist in troubleshooting and resolving critical manufacturing issues, minimizing downtime. Determine root cause of failure modes, with support from Process Engineering System Owners for more complex issues.

• Responsible for all automated method updates of processing equipment in the manufacturing space. This includes developing and implementing updates for both new product introductions and enhancements to existing product functionalities, ensuring seamless integration and minimal disruption to ongoing operations.

• Continuously monitor production processes to identify improvements that increase efficiency, reduce waste, and improve quality and support continuous improvement efforts with Process Engineering System Owners.

• Facilitate effective collaboration between engineering, manufacturing, and quality assurance teams to ensure that all manufacturing processes meet internal and external regulatory requirements via support of deviation initiation, CAPAs and out-of-tolerance investigations related to instrument calibrations.

• Mentor and develop team members, fostering a culture of continuous improvement and innovation. Additionally, provide guidance to manufacturing staff on new equipment, processes, and troubleshooting techniques.

• Ensure all manufacturing processes adhere to health, safety, and environmental regulations.

• Support the process engineering on call team and provide updated guidelines for troubleshooting.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• Minimum Education Requirement: A bachelor’s degree in chemical engineering, mechanical engineering, or related field.

• Minimum of 7 years of relevant experience as a Process Engineer, Manufacturing Engineer, or related role.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Minimum of 5 years of experience in a GMP environment preferred.

• Minimum of 3 years’ experience in a leadership or managerial role.

• Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)

• Strong leadership and team management skills coupled with analytical and problem-solving skills to perform technical tasks alongside the team.

• Ability to excel in a fast paced, multiproduct environment.

• Excellent interpersonal and communication skills (verbal and written) are required.  Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.  Technical writing skills required.

• Demonstrated ability to manage own time and deliver to program timelines.

• Proven ability to multitask.

• Self-directed with effective analytical and problem-solving skills.  Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.

• Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.  Must be able to be able to find true root cause and path forward for complex problems. 

• Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.

• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.

• Ability to interact well