Thermo Fisher Scientific Supervisor, GMP Maintenance in Plainville, Massachusetts
Job Title: Supervisor, GMP Maintenance
Location: Plainville, 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 vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and powerful Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases
How will you make an impact?
The GMP Maintenance Supervisor will be responsible for the new VVS commercial facility in Plainville, MA. This supervisor will act as the technical support SME and will assist in coordination with customers, and the other mechanicals for all daily operations. Responsible for supporting and maintaining the GMP clinical/commercial manufacturing facility process equipment and Pilot Plant and QC laboratory equipment. Also aid with utility systems, including HVAC, WFI, PW, RO, Pre-Treatment, Incubators, Compressed Gases, Waste Neutralization, and other building systems. Respond to utility and equipment related alarms, and maintenance issues during manufacturing campaigns. Identify areas of potential, to improve operational performance and compliance. Be a leader in safety procedures and safe practices and assist coworkers on PPE choices, LOTO, and ECPs for any repairs or maintenance. Provide technical support and troubleshooting for manufacturing support equipment during shift. The role will also be responsible for providing maintenance support for new processing equipment, installations, and modifications to existing equipment. Documents all work in CMMS, and equipment logbooks. Coordinates and participates the “On-Call” duties providing 24/7 Maintenance support.
What will you do?
Oversee GMP facilities operations of a new cGMP Manufacturing facility.
Lead and develop a team to run daily operations - team works in shifts; flexible working hours may be required
Prioritize, and monitor work assigned the CMMS system for the GMP Process Mechanics.
Develop appropriate programs and systems related to maintenance and operations of GMP equipment and utilities.
Support all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Partner with manufacturing and engineering to ensure appropriate maintenance and calibration intervals for equipment and instrumentation.
Assist in budget related to facilities operations.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
Assist in the development and execution of site safety policies and procedures. Partner with EHS to champion site safety practices.
Complies with U.S. Food and Drug Administration (FDA) regulations, EMA (European Medicines Agency), other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Any other duties as assigned
How will you get here?
High School Diploma and 8+ years’ experience in GMP Maintenance, or bachelor’s degree and 5+ years’ experience in GMP operations.
Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA required.
Understanding of CMMS Systems.
Working knowledge of Building Automation Systems, Microsoft Windows, Excel, PowerPoint, Blue Beam, Procore, SAP, BlueMountain and similar systems.
Working knowledge of equipment/hardware/software testing and associated protocols and lifecycle documentation requirements.
Knowledge, Skills, Abilities
Excellent communication, technical, organizational, and interpersonal skills are crucial.
Flexibility to accommodate to rapidly changing priorities and deadlines.
May be required to obtain Massachusetts Special Licensure to operate boiler onsite
Must be prepared to lead, work in, and embrace a team-based culture
Ability to lift 50+ lbs,
Ability to walk, climb stairs, bend, crawl, or reach for an extended period.
Must be available to work evenings and/or weekends as needed to maintain facilities and equipment.
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 .
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.
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