Job Description

　　Lead GMP Maintenance Technician

　　Job Title: Lead GMP Maintenance Technician 

　　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 Lead GMP Maintenance Technician: A motivated self-starter with prominent levels of initiative. This technician will act as the technical support SME and 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 Lead GMP Maintenance Technician will be responsible documenting all work in CMMS, and process equipment logbooks. Participates in the “On-Call” duties of providing 24/7 Maintenance support. 

　　What will you do?  

　　Maintains GMP facilities operations of a new cGMP Manufacturing facility. 

　　Performs preventative, routine, and non-routine maintenance on GMP equipment.  

　　Tracks process and utility systems through the BMS and Delta V control systems. 

　　Documents all work on validated systems including equipment logs, readings, and alarm investigations. 

　　Investigates process equipment failures and serves as system expert for troubleshooting and repairs. 

　　Responds to critical alarms for process systems. 

　　Responds to adverse conditions and implements corrective actions to restore process equipment and/or utility 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 Facilities Manager. 

　　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. 

　　How will you get here?  

　　Education 

　　Any licensure or certifications are preferred.  

　　High School Diploma / GED required and 5+ years’ experience in GMP Maintenance, or bachelor's degree and 3+ years’ experience in GMP operations. 

　　Experience 

　　Experience with a Computerized Maintenance Management System required. 

　　Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA required. 

　　Knowledge, Skills, Abilities 

　　Direct experience supporting manufacturing 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. 

　　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.