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Suite Coordinator

The primary role of the Suite Coordinator within the Devens Single Use Manufacturing department is to provide support to upstream or downstream group in the area of audit readiness, manufacturing continuity and recipe coordination
Other duties will include coordination of GMP documentation creation and revision and CAPA closure
MAJOR DUTIES AND RESONSI-BILITIES
Schedule Maintenance
Works with Managers and Bioprocess leads to maintain, publish and communicate details of the production schedule. Act as point of contact for all facility related work and partner with Technical services /Facilities to prioritize work execution. Engage with Technical services/Facilities to drive work efficiently and implement robust solutions minimizing corrective maintenance and repeat work orders. Manages sample requests and coordinates protocol execution within the production schedule. Responsible for facilitation of changeover activities including service request and work order tracking and area clearance walkthroughs.
Metrics Maintenance
Maintains Functional Area Metrics and may provide input for metric selection.
5S program tracking
Training reports for area management visibility.
Other metrics as defined.
Compliance
Provide training to functional areas as required (arising out of CAPA, and for investigation) Work with relevant manufacturing SME and Training department to ensure that training (PQC) documents are updated and approved according to site requirements Organize weekly cross functional GMP walkthroughs in the manufacturing facility, track actions and follows up with relevant party to resolve. Aim is to ensure facility is audit ready at all times Partake in any Internal audits within manufacturing and follow up to close out any related CAPA?s Work with functional area OpEx advocates to prioritize OpEx ideas into actionable implementation plan (procedural or recipe updates)..
Production Facilitation
Work with supply chain to maintain consumable levels (kan-ban), manage expiry and perform cycle counts. Order materials and new equipment as required. Order materials from central warehouse for routine use. Order batch records. Setup data reconciliation (Primr) sheets prior to operation execution. Act as Recipe Coordinator for any recipe revisions (Syncade BOM)
KNOWLEDGE AND SKILL
Associates degree preferred or at least 3-5 years relevant experience biotech experience
Experience with Syncade, DeltaV, Maximo, and Trackwise required
3-5 years of experience in highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations Must possess excellent communication skills as well as proven written and verbal skills
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
High proficiency required in Microsoft Office applications especially Word, Excel and PowerPoint
Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives
Position requires flexibility to quickly adapt to changing work environment and schedules. Weekend, holiday and overtime may be required
Proficiency with Syncade and DeltaV a must
Experience with Trackwise, Maximo, and SAP preferred
Lean process awareness required. Yellow/Green belt certification preferred.
CONTACTS
The suite coordinator will drive audit readiness (training/facility upkeep), ensure manufacturing continuity (materials/small equipment availability) and coordination of recipe changes
This will necessitate continual interaction with cross functional teams, including Quality (QA and training groups), Manufacturing Engineering, MS&T, Automation, Validation, Tech Services and Facilities department.
Regular reports (training gaps, facility walkthrough trends,etc...) will be generated and presented to a management cross functional team as required
WORKING CONDITIONS
Work is performed in a state-of-the-art large scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustic, and steam
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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