
Job Information
Thermo Fisher Scientific Associate III, Downstream Manufacturing in Plainville, Massachusetts
Job Description
ob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
Plainville, MA - Viral Vectors (VVS) Plainville
How will you make an impact?
Operates equipment used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. (Serves as SME) Acts as a SME (technical expertise) and demonstrates mastery of tasks and processes in manufacturing drug product injectables in a cleanroom environment and following GMP standards. Conduct quality investigations and support process optimizations.
What will you do?
Acts as a high-level technician on the floor providing guidance to other technicians and driving daily operations.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
SME or Expert on 1 Unit Operation. Obtains samples of batches/products in accordance with company procedures; submits samples to required functional areas for testing and to determine specific properties. Records/analyzes results and takes appropriate action.
Responsible for the upkeep of manufacturing equipment. Recognizes equipment and product problems, notifies supervisor and/or troubleshoots errors in order to achieve optimum production levels.
Review, revise, & author manufacturing batch records. Collaborate with Quality & PD to review & signoff on executed batch records. Own the batch record reconciliation. Review, revise, & Author WIs/SOPs.
Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the on-time closure of Nonconformance’s/ CAPAs
Lead PPI initiatives and continuous improvements.
Receives and checks raw materials and formulation deliveries and completes appropriate records in accordance with company procedures (MFP’s/EOP’s/LOP’s/SOP’s).
Active participant of performance huddles and assist supervisors to plan out and populate process schedules.
How will you get here?
Education
High School Diploma or equivalent required.
Bachelor’s Degree in related field preferred.
Experience
- 2 years of relevant experience in warehousing, manufacturing, or highly regulated environment.
Knowledge, skills and Abilities
Full GMP understanding. Demonstrated ability to lead and mentor.
Strong communication skills (verbal and written).
Good autonomous problem-solving skills.
Strong attention to detail.
Ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays.
Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
PHYSICAL DEMANDS/FACTORS:
While performing the duties of this job, the employee:
Ability to function in a dynamic environment and balance multiple priorities simultaneously.
Ability to learn new software and tools quickly.
Ability to make decisions and work with minimal to moderate supervision.
Ability to aseptically gown and/or sterile gown as needed.
While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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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