Engineer II, Manufacturing Process Engineer

The Role

In this role, you will be responsible for supporting the day-to-day operations of our cutting-edge manufacturing processes at Norwood. This role will be instrumental in reducing manufacturing events, minimizing user interventions, and enhancing product quality and safety standards through direct engineering support, troubleshooting acumen, and continuous improvement initiatives. Your expertise will not only ensure the smooth and efficient production of our products but also drive the innovation and optimization of our manufacturing space. Applicants should have a blend of technical expertise, problem-solving skills, and a collaborative spirit to support our mission and contribute to our growth in a fast-paced, multiproduct environment.

Here’s What You’ll Do

• 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.

• Manufacturing Support: Assist in the setup/ changeover of manufacturing systems and processes. Provide hands-on support to ensure equipment and machinery are functioning optimally. Perform operational assessments to ensure procedures and tools are in place.

• Troubleshooting & Triage: Act as the first point of contact for any manufacturing issues. Quickly diagnose and resolve technical problems independently to minimize downtime. Determine root cause of failure modes, with support from Process Engineering System Owners for more complex issues.

• Automated Method Updates: 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.

• Process Optimization: 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.

• Documentation: Meticulously document all activities related to manufacturing setup, troubleshooting, and triaging, and automated method updates per applicable SOPs and guidelines.

• Quality: Work closely with the Quality Assurance team 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.

• Training: Provide training and guidance to manufacturing staff on new equipment, processes, and troubleshooting techniques. Drive learning between MFG and F&E.

• Safety Compliance: Ensure all manufacturing activities are conducted in accordance with health, safety, and environmental regulations.

• On-Call: 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 2 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 2 years of experience in a GMP environment preferred.

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

• Strong analytical and problem-solving skills.

• 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.