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Thermo Fisher Scientific Associate I, Manufacturing in Cambridge, Massachusetts

Job Title: Associate I, Manufacturing

Requisition ID: 122780BR

When 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.

JOB SUMMARY/OBJECTIVE:

The Manufacturing Associate 1 is an associate with little to moderate level of technical expertise and experience. An MA1 may independently perform routine operations commensurate with their experience and training. An MA1 participates in the day to day operation of a cGMP compliant Manufacturing facility. The MA1 must be technically capable with a basic theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a basic understanding of current GMP and safety standards.

ESSENTIAL JOB FUNCTIONS: Percentage of Time Spent

Job Function (In order of %)

50%- 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.

25%- 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.

10%- Use and Navigate with basic to moderate understanding manufacturing systems for process operation and process performance. MA1 must be able to understand Thermo Fisher policies, programs and procedures commensurate with their experience

under the guidance of a qualified trainer.

10%- Reviews departmental documentation (e.g., Standard Operating Procedures, PBR's), data, and trends. Participates in revisions, providing input, as necessary.

5%- Participates in the investigation of non-conformances in compliance with quality procedures, policies and regulations.

POSITION REQUIREMENTS:

  • MA1 must be able to understand basic GMP manufacturing activities including process performance with minimal to moderate supervision. An MA1 must be able to recognize situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior operators or area management

    • The MA1 must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
    • The MA1 must be able to recognize operational documents that are GMP compliant, accurate and complete. MA1 must understand the safe performance of activities on the shift in order to prevent releases, accidents and injuries.

EDUCATION AND QUALIFICATIONS:

Bachelor's Degree in Life Sciences is preferred OR

  • 0-3 years' industry related experience with a Bachelor's Degree in Life Sciences

  • 1-3 years' industry related experience with a Associates Degree/certificate program

  • 2-4 years industry related experience with a high school diploma

  • Strong interpersonal and communications skills; written and oral.

  • Solid understanding of applicable regulatory requirements.

PHYSICAL DEMANDS/FACTORS:

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.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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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