Job Description

Job: Sr Associate, Manufacturing

Role ID: 145257BR

When youre part of the team at Thermo Fisher Scientific, youll 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 youll 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?

The incumbent has substantial understanding of primary work (cleaning, steam sterilization, disinfectant prep, stocking, waste management, etc.). In this role you are apart of a highly skilled, engaged workforce and creating a positive work environment. The incumbent completes the following tasks in a resourceful and effective way: prepares disinfectants, autoclaving cleaning supplies, and cleaning production rooms and associated support areas and corridors, the disposal of biohazard waste, the stocking of gowning materials and locker room supplies, the removal of regular trash from the warehouse areas and locker rooms.. The incumbent also maintains proper organization and cleaning of rooms and equipment. The incumbent must also maintain equipment logs and document equipment usage and document all other assigned cleaning activities as required by written procedures. The individual uses judgment to resolve issues or to deliver outcomes. This position requires a solid understanding of technical, operative, and administrative methods. The associate identifies and communicates ThermoFIshers values, policies, procedures, and strive to be efficient.

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?

Education

Required:

High School Diploma and 2 year of industry related experience.

Preferred:

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

Experience:

* Manufacturing experience required
* Cleanroom experience required
* 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, 7:30 AM to 4:30 PM on a FLEX schedule. Overtime, weekend and holidays required to meet project timelines as necessary.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling 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.