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System One Associate Scientist in Devens, Massachusetts

Title: Associate Scientist

Location: Devens, MA

Start date: ASAP

Responsibilities:

  • The contractor position provides technical support to Cell Therapy Facility Manufacturing processes in a GMP environment.

  • Functions as a technology and process subject matter expert

  • Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing

  • Facilitate deviation prevention and deviation closure through site quality systems

  • Analyze and summarize manufacturing data to support impact assessments and investigations

  • Owner of change controls for process and procedure changes

  • CAPA owner for Manufacturing improvements

  • Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records

  • Leads technology transfer efforts for new processes and product implementation

  • Train and support GMP operators on new procedures, processes and changes

  • Applies continuous improvement tools to identify and close procedural and compliance gaps

  • Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.

  • Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements and participating on impact assessments

Requirements:

  • Bachelor’s Degree with minimum 2 years of relevant industry experience/ MSc/ PhD degree in Science or Chem/Bio Engineering

  • 1-2 years BioPharma industry experience

  • Highly motivated, ability to work independently as well as have excellent teamwork skills

  • Understanding of bioprocess principles

  • Demonstrate innovative problem-solving ability, and knowledge of cellular bioprocessing/ drug product/ aseptic processing unit operations preferred.

  • Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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