When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Executes process documentation in a fast-paced manufacturing environment.
- Maintains cleanliness required of equipment, work areas, and facility with assistance of assigned personnel.
- Prepares manufacturing suites and components for Production Batch Record execution.
- Performs cleaning of the cGMP suites. Executes Production Batch Records.
- Executes Work Orders.
- Keeps proper Personal Protective Equipment (PPE) and gowning materials supplied in gowning suite.
- Maintains cGMP materials inventory according to applicable Standard Operating Procedures (SOP’s).
- Complies with established waste disposal operations.
- Performs equipment qualification.
- Cleans and visually inspects the processing equipment, tools, and utensils for cleanliness per the appropriate SOP and documents those activities.
- Attaches and changes status tags as to the cleaning status of equipment.
- Ensures that all cGMP equipment and parts are properly labeled.
- Performs other technician responsibilities as necessary.
- High School Diploma/GED required.
- Proven track record of producing an excellent work product with a high degree of accuracy. Ability to multi-task and handle shifting priorities in a fast-paced manufacturing environment. Strong proficiency in Microsoft Office Suite (Word and Excel).
- Effective written and interpersonal skills.
- Associate’s or Bachelor’s degree.
- One (1) year of production experience in the pharmaceutical industry.
- Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications.
- Pharma or biotech experience highly preferred.
Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing suite setting. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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