GMP Manufacturing Operations Coordinator

Dexian; Harvard (MA); On-site; USD 40,000 - 41,000; Full time

Job summary

Dexian is seeking a Manufacturing Operations Associate to support equipment and systems in a multi-product manufacturing environment on a 6+ month contract. The role involves cross-functional coordination with Technical Services, Facilities, and Engineering to plan downtime, manage tagout, and drive efficient work execution.

Responsibilities include tracking spare parts, coordinating vendor activity, supporting audits and CAPAs, and maintaining GMP readiness.

Qualifications

• Associate degree or equivalent in related field or 1–3 years in a cGMP biopharma/pharma setting.
• Experience with Infinity, Syncade, DeltaV, SAP and Maximo preferred.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Able to manage multiple priorities in a dynamic, cross-functional environment.
• Lean process knowledge; Yellow Belt or Green Belt preferred.
• Willingness to work weekends/holidays as needed.

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 coordinate downtime planning and equipment tagout activities.
• Engage cross-functional teams to drive efficient work execution and implement robust solutions to minimize repeat work orders.
• Track small equipment needed for repairs and coordinate with vendors for service requests.
• Support service requests, work order completion tracking, and cross-functional activities.
• Participate in internal audits and CAPA closures, maintain GMP readiness and address gaps.
• Support spare parts program and monitor reagent availability to sustain operations.
• Coordinate OpEx and TREx initiatives and assist with approved enhancements.
• Assist with quality events and supplier corrective actions while ensuring timely resolution.
• Coordinate inventory control and 5S metrics to support facility organization and continuous improvement.

Skills

Self-starter

Time management

Organizational skills

Cross-functional collaboration

Adaptability

Education

Associate degree or related field

Tools

Infinity

Syncade

DeltaV

SAP

Maximo

Job description

Dexian is seeking a Manufacturing Operations Associate to support equipment and systems in a multi-product manufacturing environment on a 6+ month contract. The role involves cross-functional coordination with Technical Services, Facilities, and Engineering to plan downtime, manage tagout, and drive efficient work execution.

Responsibilities include tracking spare parts, coordinating vendor activity, supporting audits and CAPAs, and maintaining GMP readiness.