Plainville, Massachusetts, us Office and Administrative Support Occupations
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When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals
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 Metrology Supervisor will be responsible for supporting the new VVS Commercial facility in Plainville, MA. The Metrology Supervisor is the front-line contact for scheduled and unscheduled calibrations and metrology services. Assist in establishing the adequate processes, procedures, tools and training to the calibration organization that performs troubleshooting, instrument configuration activities, support regulatory audits, periodic review of instrument performance, calibration, coordination of activities with impacted areas and external suppliers, schedule preventive and corrective calibrations and provide daily support to the instrumentation clients through the site. Must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Accountable for the Instrumentation/Calibrations group to assure that required process, laboratories, utilities and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g. FDA, EQB, OSHA, etc.).
Act as a system administrator for CMMS, that supports our equipment asset management, work-order administration and calibration functions.
Assists in the development of departmental budget to ensure area consumables, external services, personnel training, tools and facilities are provided to personnel and areas serviced.
Develop department SOPs
Perform/Evaluate Change Control, Quality Events and CAPA/Stand Alone action related documentation and instrument performance and ensures its adequacy and on time completion.
Executes employees’ performance improvement plans, development and disciplinary actions as required.
Provides sound problem solving techniques to resolve issues and calibration problems.
Assist in the definition and need of Capital Appropriation Requests (CAR’s), their timeline implementation.
Prioritizes the use of resources to most effectively achieve business goals within budget.
Deals effectively with internal and external sources.
Review and approval of maintenance records.
How will you get here? Education:
High School diploma with eight (8) years’ experience or Bachelor’s Degree with five (5) years’ experience.
Five (5) years’ experience in instrumentation technology for processing, laboratories, utilities and facilities equipment in a pharmaceutical manufacturing environment.
Knowledge, Skills, Abilities:
Knowledge of cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
Ability to organize and prioritize workload and meet deadlines in a highly technical and rapidly changing environment.
Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, Blue Mountain, MAXIMO, etc.
Ability to read and interpret complex mechanical, pneumatic and electrical blueprints.
General knowledge in automated equipment functionality and architecture.
In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment/instruments as applied to pharmaceutical production environment.
Good technical writing skills and ability to review SOPs and work instructions
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the calibration work.
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.