Upstream Associate IIl - 12hr. Rotation Shift (Days)

Work Schedule

Flex 12 hr 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, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location / Division / Shift
Thermo Fisher Scientific Viral Vector Services (VVS), is a rapidly growing, dynamic gene therapy contract development and manufacturing organization. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

• Shift Hours: Day Shift 12 hrs. rotation (7a-7p)
• Plainville, MA - 5 Commerce Boulevard

Summary

The Manufacturing Associate III, Upstream will report to a shift supervisor and work with peers to conduct manufacturing operations in Upstream per cGMP in a viral vector production environment. In addition, the associate will be cross trained to be able to perform functions across multiple manufacturing departments. The successful candidate will ensure to maintain proper training and compliance to cGMP standards as well as abide by Thermo Fisher Scientific corporate standards. A typical work week will be a rotating 12 hours shift structure for support of GMP manufacturing operations.

The Associate in this role will be part of a cohesive team responsible for the execution of bioprocessing activities. The Associate will be required to follow procedures to ensure compliant execution of manufacturing activities The Manufacturing Associate may also be needed to support equipment documentation investigations and improvement initiatives within the manufacturing operations The Associate works under the supervision and direction of Lead Associate and Manufacturing Supervisor

Responsibilities

• Demonstrates safe work habits and adheres to safety procedures and guidelines
• Participate in Tier 1 meetings
• Supports team preparedness and room preparation activities
• Supports maintenance of GMP Kanban in support of manufacturing operations
• Support continuous improvement m process operations and systems.
• Support tech transfer activities.
• Seeks and welcomes feedback and responds to coaching
• Expected to spend at least 80 - 90% of the time on the manufacturing floor
• Working closely with related functional areas to achieve production goals and timelines.
• Find opportunities and implement efficiency improvements.
• Manage inventory supplies.

Education/Experience/Requirements

• High School Diploma/GED/Equivalent Education is required.
• 1+ years' experience in a cGMP environment, warehouse, or related experience.
• Ability to function in a fast-paced, dynamic environment with multiple priorities simultaneously.

Knowledge/Skill/Abilities

• Demonstrate strong attention to detail.
• Able to read and follow procedures.
• Ability to maintain aseptic qualification.
• Ability to maintain qualification to work in a cleanroom environment.
• Ability to work closely and effectively in a team environment.
• Demonstrate initiative and drive to accomplish the job timely accurately and safely the first time is required.
• Ability to apply knowledge of Good Manufacturing processes.
• Ability to apply knowledge and skills in pharmaceutical processes equipment, instrumentation and procedures.
• Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

Physical Requirements

• Gown aseptically and/or sterile gown as needed
• Write, read/review written documentation for extended periods of time Specific vision requirements for this job include close vision, distance vision color vision peripheral vision depth perception and ability to adjust focus
• Regularly required to talk and hear
• Able to lift push or pull up to 50lbs (as needed)
• Required to sit and stand for ex