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Aseptic Manufacturing Technician II
2 months ago
Position Overview:
The Formulation Technician II plays a crucial role in the production of pharmaceutical products, ensuring compliance with established standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP).
Key Responsibilities:
- Oversee the manufacturing of pharmaceutical products in alignment with area SOPs and cGMP regulations.
- Document and verify production activities meticulously in batch records, logbooks, and controlled forms.
- Execute essential tasks for drug product manufacturing in an aseptic filling environment, including:
- Maintaining cleanliness in cGMP areas
- Conducting line changeovers
- Preparing parts for production
- Performing filter integrity testing
- Operating parts washers and autoclaves
- Loading and unloading trays
- Managing the filling isolator
- Troubleshooting equipment alarms
Qualifications:
- High School Diploma or equivalent with a minimum of 2 years of experience in manufacturing; experience in pharmaceuticals or mechanical fields is preferred.
- Associate's degree with at least 1 year of manufacturing experience.
- Bachelor's degree is preferred, though no manufacturing experience is required.
- Basic mathematical skills are essential.
- Strong verbal and written communication abilities.
- Capability to adhere to SOPs effectively.
Physical Requirements:
- Work in a clean-room environment with controlled temperature and humidity, maintaining low ambient noise levels.
- Utilize gowning procedures, including gloves, hair and beard nets, face covers, and safety glasses, while avoiding makeup and jewelry.
- Employ Personal Protective Equipment (PPE) and understand chemical hygiene protocols.
- Occasionally lift and handle up to 25 pounds unassisted.
- Utilize hand tools and equipment, requiring forceful gripping, grasping, pushing, and pulling.
- Position necessitates ordinary ambulatory skills and physical coordination to navigate office locations; ability to stand, walk, stoop, kneel, and crouch for extended periods; manipulation of light to medium weights (10-35 pounds).
Benefits:
Thermo Fisher Scientific offers competitive compensation, an annual incentive plan, comprehensive healthcare, and a variety of employee benefits. Join an innovative organization that values integrity, intensity, involvement, and innovation, and provides exceptional career development opportunities.
Accessibility/Disability Access:
Thermo Fisher Scientific is committed to providing accessibility services for job seekers requiring accommodations during the application process. If you need assistance due to a disability, please submit a request with your contact information and specific accommodation details.
Thermo Fisher Scientific is an Equal Employment Opportunity/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
