Thermo Fisher Scientific Associate II, Manufacturing in Cambridge, Massachusetts
Job Title: Associate II, ManufacturingRequisition ID:122779BRWhen you're 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.Location/Division Specific InformationViral Vector Services (VVS)- Cambridge, MAHow will you make an impact?The Manufacturing Associate 2 is an associate with a moderate level of technical expertise and experience. An MA2 may perform complex activities outside of routine manufacturing operations commensurate with their experience and training. An MA2 participates in the day to day operation of a cGMP compliant Manufacturing facility. Responsibilities include performing basic to complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls under limited supervision. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities. The MA2 must be technically capable with a good theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a good understanding of current GMP and safety standards and be able to apply this knowledge in a GMP manufacturing environment during performance of routine activities. What will you do?
Prepare and process equipment and materials for manufacturing use including performing equipment functional checks, start up, basic maintenance and operation of single use bioreactors, purification columns and skids.
Perform equipment function checks, preventative maintenance, standardization and calibration, and testing of in-process samples using analytical equipment following written procedures. Clean production cleanrooms and remove waste materials.
Use and Navigate with moderate understanding manufacturing systems for process operation and process performance MA2 must be able to independently train junior associates on VVS policies, programs and procedures commensurate with their experience as a qualified trainer.
Reviews departmental documentation (e.g., Standard Operating Procedures, PBR's), data, and trends. Participates in revisions, providing input, as necessary.
Participates in the investigation of non-conformances in compliance with quality procedures, policies and regulations. Participate in innovation and continuous improvement activities.
How will you get here?POSITION REQUIREMENTS:
MA2 must be able to make decisions for moderately complex GMP manufacturing activities including process performance with minimal to moderate supervision.
An MA2 must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior operators or area management.
The MA2 must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
The MA2 must be able to understand operational documents for GMP compliance, accuracy and completeness.
MA2 must safely perform activities on the shift in order to prevent releases, accidents and injuries.
EDUCATION AND QUALIFICATIONS:
1-3 years' industry related experience with a Bachelor's Degree in Life Sciences
2-4 years' industry related experience with a Associates Degree/certificate program
3-5 years industry related experience with a high school diploma
Strong interpersonal and communications skills; written and oral.
Solid understanding of applicable regulatory requirements
While performing the duties of this job, the employee:
Needs Ability to aseptically gown and/or sterile gown as needed
Ability to work within environmental clean rooms
Ability to function in a dynamic environment and balance multiple priorities simultaneously
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.
At Thermo Fisher Scientific, each one of our 65,000 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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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