Sr. Formulation Technician: B8 Control Room & Lyophilizer Technician

at  Thermo Fisher Scientific

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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.

QUALIFICATIONS:

• High School Diploma or equivalent with 2+ years of Steriles pharmaceutical manufacturing experience required. Mechanical and/or similar experience preferred.
• Associate’s with 1+ year manufacturing experience
• Bachelor’s preferred with no manufacturing experience
• Equivalent combinations of education, training, and relevant work experience may be considered.
• 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.

• 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