Manufacturing - Business Operations Associate

Position Title: Manufacturing - Business Operations Associate

Work Location: Devens, MA

Assignment Duration: 6 Months

Work Schedule: Mon-Fri(normal business hours)

Work Arrangement: 100% onsite

Position Summary: The primary role of the Suite Coordinator within the Devens Cell Therapy MSAT department is to support and oversee a broad portfolio of MSAT-owned equipment and systems critical to Good Manufacturing Practice (GMP) operations. This role collaborates with cross-functional stakeholders, including Manufacturing (MFG) Operations, Facilities & Engineering, Quality, and Supply Chain, to support manufacturing continuity, equipment data management, capacity expansion initiatives, and audit readiness.

Background & Context: Other duties may include supporting vendor and contractor coordination, inventory oversight, quality event activities, and the creation or revision of documentation as required.

Key Responsibilities:

• Perform system administrative and coordination tasks for processing equipment and systems in a multi-product manufacturing setting.
• Act as the point of contact for facility-related work and partner with Technical Services and Facilities & Engineering to prioritize work execution, coordinate downtime planning, and manage equipment tagout and return-to-service activities.
• Engage with Technical Services, Manufacturing, and Facilities & Engineering cross-functional teams to drive efficient work execution and implement robust solutions that minimize corrective maintenance and repeat work orders.
• Act as the point of contact for tracking and ensuring that small equipment needed for repairs is addressed.
• Engage with vendors to communicate and coordinate required service requests and escort vendors during on-site activities, as required.
• Support the management of service requests and work order completion tracking, and coordinate cross-functional activities as needed.
• Participate in internal manufacturing and equipment system audits and support the timely closure of associated CAPAs. Maintain ongoing audit readiness by ensuring compliance with GMP requirements, proactively identifying and addressing gaps, and supporting a continuous state of inspection readiness.
• Support the spare parts program in collaboration with Technical Reliability Excellence (TREx) and Scheduling, monitor reagent availability, and coordinate material and equipment transfer to support routine equipment and system operations.
• Support Operational Excellence (OpEx) and TREx initiatives by coordinating improvement activities, tracking progress, and assisting with the implementation of approved enhancements to support business, operational, and reliability objectives.
• Support equipment-related quality events and supplier corrective action requests (SCARs) by facilitating cross-functional follow-up activities and tracking actions to ensure timely resolution and compliance with applicable quality requirements.
• This role may support Manufacturing Operations by coordinating physical media control and inventory activities, ensuring material availability and inventory accuracy, resolving inventory discrepancies, and maintaining Functional Area 5S metrics to promote facility organization and continuous improvement.

Qualification & Experience:

• Associate degree required, or 1-3 years of relevant experience in a cGMP-regulated biotechnology or pharmaceutical manufacturing environment, or a related scientific or engineering field.
• Experience and demonstrated proficiency with Infinity, Syncade, DeltaV, SAP, and Maximo are preferred.
• Must have the ability to work as a self-starter and manage multiple priorities in a dynamic, cross-functional, team-based environment.
• High proficiency required in Microsoft Office applications, especially Word, Excel and PowerPoint.
• Strong organizational and time management skills are required to prioritize activities in a manner consistent with departmental and sitewide objectives and contributions in alignment with project management
• Position requires flexibility to quickly adapt to changing work environments and schedules, including weekend and holiday support as required.
• Lean process knowledge is required; Yellow Belt or Green Belt certification is preferred.
• Collaborate with Quality, Manufacturing Engineering, Automation, Validation, Technical Services, and Facilities & Engineering to support equipment and system readiness.
• Prepare and present reports on equipment system walkthrough support or trends, as required.
• Reports progress on assigned deliverables and escalates constraints, risks, and roadblocks to MSAT Leadership as appropriate.

Working Conditions & Physical Demands:

Work is performed in a state-of-the-art cell therapy facility, including classified areas that require appropriate gowning and personal protective equipment (PPE). The role may involve exposure to hazardous materials, including cleaning agents.

Decision Making:

Take action, final decision, recommend

May work on assignments that are highly complex and involve cross-functional interactions where action and a high degree of initiative are required to resolve problems and develop documented recommendations.

Supervision Received:

• Incumbents act independently to determine methods and procedures on new assignments.
• Reports to MSAT manager or above.