JOB DESCRIPTION
Work Schedule
12 hr shift/nightsEnvironmental 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, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heightsJob Description
COMPANY INFORMATION
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
POSITION SUMMARY
The Sr. Formulation Technician will be able to perform tasks with little to no direction. They will provide guidance in the absence of the Lead Formulation Technician. They will be proficient in aseptic filling and manufacturing. This colleague follows written and verbal instructions using cGMP documents and operating equipment when performing the following duties. This position is a 12-hour Night shift from 6pm-6am on a 2-2-3 rotation.
Key Responsibilities:
Ensure pharmaceutical products are manufactured in accordance to area SOPs and current cGMP.
Verify and document production activities in batch records, logbooks and controlled forms.
Complete tasks vital to manufacture drug products in an aseptic filling area, including:
Cleaning cGMP Areas
Parts Preparation
Filter Integrity Testing
Operating Parts Washers and Autoclaves
Performing Tray Loading
Operating the Filling Isolator
General Material Handling
Troubleshooting Equipment Alarms
Designated Trainer/Certified SME
Education:
High school diploma or equivalent required.
Experience:
Required: Minimum of two years of Steriles pharmaceutical manufacturing experience required.
Mechanical and/or similar experience preferred.
Equivalent combinations of education, training, and relevant work experience may be considered .
Knowledge, Skills, Abilities:
Excels in a team environment.
Basic math skills.
Attention to detail while maintaining a quality product.
Ability to perform repetitive work duties.
Ability to follow SOPs.
Ability to concisely communicate with Production leadership to accept daily assignments and report any relevant production-related information.
Ability to schedule the team’s activities and drive priorities
Strong communication skills
Proactive in identifying quality opportunities
Flexibility/willingness to adapt to operational needs
PHYSICAL REQUIREMENTS:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 25-50 pounds, occasionally pushing or pulling more than 100 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate 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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