Job Title: Suite Coordinator, Manufacturing

Work Location: Lexington, MA

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The suite coordinator is an individual who works closely with manufacturing leadership and other departments to support daily manufacturing operations. A suite coordinator is the responsible liaison between the Manufacturing group and other supporting groups/vendors (Facilities, Scheduling, Materials management, Cleaning Contractors, etc.) This role will work cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and provide support with regard to the CMMS program and SAP inventory management. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness and executing routine GEMBA. The suite coordinator must be technically capable with a good theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes. The successful candidate must have a good understanding of current GMP and safety standards and be able to apply this knowledge in a GMP environment.

What will you do?

• Works cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and maintaining schedule adherence
• Provide support with regard to the CMMS program working with CMMS (preferably Blue Mountain Regulatory Asset Manager system) Work Record systems
• Perform work record review to close records, data mining, oversight for aging records, weekly-monthly report assessments
• Support material management utilizing SAP and Kanban inventory scheduling systems
• Coordinate material transfer from warehouse to cleanroom points of use
• Assist in organizing and maintaining inventory to support MFG activities
• Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control Teams, Quality Control and Quality Assurance
• Follows verbal and written procedures; accurately completing appropriate documentation
• Demonstrates ability to troubleshoot basic issues in relation to GDP
• Monitor and maintain clean room disinfection program and ensure schedule adherence
• Support Operations needs that may include but is not limited to ordering of supplies, and backorder reporting, etc.
• Support regulatory audit requirement

How will you get here?

• A suite coordinator must be able to work in a fast-paced environment and have strong planning, organization and multitasking skills.
• A suite coordinator must be able to understand cGMP & GDP requirements and have a solid understanding of applicable regulatory requirements
• A suite coordinator must be able to work towards solutions to given problems with and operate under cGMP requirements.
• A suite coordinator must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to area leads and area management.
• A suite coordinator must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.

Education

• 1-3 years’ industry related experience with a Bachelor’s Degree
• 2-4 years’ industry related experience with an Associates Degree/certificate program
• 3-5 years industry related experience with a high school diploma

Knowledge, Skills, Abilities

• Experience with SAP and inventory control
• Experience with Blue Mountain Regulatory Asset Manager system
• Skilled in Microsoft office applications

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.