Lead Formulation Technician at Thermo Fisher Scientific in Bend, Oregon

Job Description:

Work Schedule

First Shift (Days)



Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials



Job Description




Summary:



Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Manages process documentation in a fast-paced, flexible manufacturing environment.



Crucial Functions:



1. Progresses towards Subject Matter Expertise on multiple process trains.


2. Reviews, approves, and updates quality documents.


3. Executes Production Batch Records to make pharmaceutical products.


4. Reviews completed Batch Records for compliance prior to QA review.


5. Assists with schedule adherence via prioritization of daily tasks.


6. Maintains Qualified Subject Matter Expert status to deliver employee training.


7. Drives continuous improvement activities and educates peers.


8. Maintains cleanliness required of equipment, work areas, and facility; performs visual equipment inspections.


9. Prepares manufacturing suites and components for Production Batch Record execution.


10. Operates in a safe manner, wears appropriate PPE, and identifies and raises any safety hazards.


11. Follows established waste disposal operations.


12. Mentors new team members.


13. Serves as backup for Team Lead as appropriate.


14. Supports new equipment commissioning and qualification activities.


15. Supports audits as needed.


16. Follows all appropriate SOPs, Good Documentation Practices, and Data Integrity procedures.


17. Exhibits the 4i Values (Integrity, Intensity, Innovation, and Involvement).


18. Performs other responsibilities as vital.



Education:



HS Diploma or equivalent required.



Experience:



5+ year of work experience in manufacturing/production environment; demonstrated pharma related formulation/production experience.



Equivalency:



Equivalent combination of education, training, and meaningful work experience may be considered.