Associate 1, Support Operations Manufacturing

Thermo Fisher Scientific Inc. Alachua , FL 32615

Posted 2 months ago

Job Description:

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.

Location/Division Specific Information

The Manufacturing Associate is member of the GMP Manufacturing department in Alachua, Florida whose mission is to deliver a consistent and reliable supply of quality released viral vector drug substance and/or drug product that meets regulatory and internal Quality and Safety standards.

How will you make an impact?

This position requires routine hands-on bioprocess manufacturing within a cGMP cleanroom commensurate with the individual's level of technical expertise, training, and qualification strictly following defined procedures. Responsibilities include performing basic bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation of performance, monitoring of processing equipment, processes, and control systems within a GMP cleanroom. The Manufacturing Associate is expected to keep the GMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times. The Manufacturing Associate will adhere to all Safety and Quality standards of the organization contribute to continuous improvement in the areas of Safety, Quality, and Delivery.

What will you do?

  • Perform cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule

  • Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards

  • Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards

  • Ability to learn biopharmaceutical manufacturing processes including but not limited to: the use of autoclave, buffer preparation, cleaning, stocking, disinfectant prep, decontamination, fumigation, waste management, equipment maintenance, materials movement, staging, etc.

  • Adheres to the production schedule ensuring on-time delivery and efficient production logistics

  • Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)

  • Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities

  • Other duties as assigned

How will you get here?

Required:

  • High School Diploma

Preferred:

  • Associate Degree in Life Sciences, Engineering, or Biotechnology or certificate program and one to three years' industry related experience

Experience:

  • Manufacturing experience preferred

  • Cleanroom experience preferred

  • Experience using SAP preferred

  • Autoclave experience preferred

  • Buffer or media preparation experience preferred

Knowledge, Skills, Abilities

  • Strong interpersonal and communications skills; written and oral

  • Solid understanding of applicable regulatory requirements

  • Strong working knowledge of Microsoft Office

  • Ability to deliver high quality documentation paying attention to detail

  • The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

Work Hours: Monday through Friday, 3:00 PM to 11:30 PM on a FLEX schedule. Overtime, weekend and holidays required to meet project timelines as necessary.

At Thermo Fisher Scientific, each one of our 70,000 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.

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Associate 1, Support Operations Manufacturing

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