Sr Mfg Equipment Maintenance Technician (Nights)
Thermo Fisher Scientific

Job Description

Job Title: Sr. GMP Maintenance Technician (Nights)

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 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 Sr. GMP Mechanical Technician: A motivated self-starter with prominent levels of initiative. This technician will assist in support with customers, and the other mechanicals for all daily operations. Responsible for supporting and maintaining the GMP clinical/commercial manufacturing and facility process equipment, Pilot Plant and QC laboratory equipment. Respond to utility and equipment related alarms, and maintenance issues during manufacturing campaigns. Complete preventative and corrective maintenance on equipment including but not limited to bioreactors, mixers, centrifuges, TFFs, refrigerators, freezers, incubators and stability chambers. Identify areas of potential, to improve operational performance and compliance. Uphold safety procedures and safe practices. The role will also be responsible for providing general maintenance support for new processing equipment, installations, and modifications to existing equipment. The GMP Mechanical Technician will be responsible for documenting all work in CMMS, and equipment logbooks. Participates in the "On-Call" duties of providing 24/7 Maintenance support. This role will begin as day shift M-F (7:00AM-3:30PM), with the goal to transition to a rotating 12-hr. (2 days on 3 days off, 3 days on 2 days off, 7PM to 7AM) Night shift.

What will you do?

• Maintains facilities operations and integrity of a cGMP Manufacturing facility.
  
• Performs preventative, routine, and non-routine maintenance on facilities equipment.
  
• Documents all work on validated systems including equipment logs, readings, and alarm investigations.
  
• Investigates equipment failures and serves as system expert for troubleshooting and repairs.
  
• Responds to critical alarms for utility systems.
  

• Responds to adverse conditions and implements corrective actions to restore utilities equipment to normal operation.
  
• Ensure contractor compliance with EHS policies and procedures, including Hot Work and Lock Out Tag Out.
  
• Works independently but collaborates with equipment Responsible Engineers.
  
• The ability to lift 50 lbs to a height of 4 feet.
  
• Follows standard operating procedures (SOP).
  

• Assesses equipment needs and provides recommendations on system improvements.
  
• Performs small projects as assigned by GMP Maintenance Supervisor.
  
• Participate in the GMP Process on-call responsibilities.
  
• 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.
  

• High School Diploma / GED required and 3+ years' experience in GMP Maintenance.
  

• Experience with a Computerized Maintenance Management System preferred.
  
• Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA preferred.
  
• Any licensure or certifications are preferred.
  

• Direct experience supporting utility systems within a regulated industry. Trained in formal problem-solving techniques, and computer skills. Experience with most of the following unit operations or technologies.
  
• Ability to aseptically gown and/or sterile gown as needed.
  
• Single Use Technology such as SUBs and SUMs.
  
• BMS (Building Management System)
  
• Practical knowledge of GMP's and working in an SOP environment
  
• Requires excellent oral and written communication skills.
  
• Ability to work independently.
  
• Prior experience as a GMP Maintenance Technician in a complex pharmaceutical or biopharmaceutical manufacturing environment.
  
• Must be available to work evenings and/or weekends as needed to maintain facilities and process equipment.