Thermo Fisher Scientific Manufacturing Operator in Bend, Oregon

Job Description

Summary:

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.

Essential Functions:

Maintains cleanliness and safety required of equipment, work areas, and facility with assistance of assigned personnel. Prepares manufacturing suites and components for Production Batch Record execution. Executes Production Batch Records. 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. Cleans and visually inspects the processing equipment, tools, and utensils for cleanliness per the appropriate SOP and documents those activities. Monitor manufacturing operations including all procedures, batch records, and components, to see that cGMP requirements are met. Train personnel in manufacturing techniques and other support aspects of Manufacturing. Document manufacturing technician training. Support all aspects of manufacturing and help ensure personnel are following SOPs. Review Master Batch Records. Review Production Batch Records and all other documentation prior to submitting to QA. Performs other Manufacturing operator responsibilities as necessary.

Education:

Bachelor’s degree and/or military experience preferred; HS degree required.

Experience:

Three-Five (3-5) years of production experience in the pharmaceutical industry preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications preferred. Pharma or biotech experience highly preferred. 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.

Physical Requirements:

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.

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.