Sr. Formulation Technician - 2nd Shift

About the role

Thermo Fisher Scientific Inc. is seeking an individual with outstanding work behaviors to join our team as a Downstream Processing Technician III in St. Louis. This is a manufacturing role where you will have the opportunity to contribute to the production of world-class products that make a difference in people's lives. As a Downstream Processing Technician III, you will play a meaningful role in our ambitious mission to enable our customers to make the world healthier, cleaner, and safer. You will work closely with a team of proven professionals to compete in a fast-paced environment, ensuring flawless execution of downstream manufacturing processes.

Responsibilities

• Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions
• Assist with batch record reconciliation
• Able to complete all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies
• Documentation of all activities to meet cGMP requirements
• Daily record review, tasks, and databases
• Complete preventative maintenance and work notifications tasks on time
• Perform equipment testing and routine trouble-shooting
• Oversee and perform timely consumption of materials and completion of quality documentation in appropriate systems
• Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations
• Complete validation protocols with minimal supervision or direction
• Schedule activities and coordinate the shift huddle in absence of the supervisor
• Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on a variety of downstream processing steps techniques
• Participate in shift exchanges, 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities)
• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures

Requirements

• Education: HS Diploma/ GED required, bachelor's degree preferred
• Experience: 2 years relevant work experience is required
• Experience in cGMP environment preferred

Knowledge, Skills, Abilities

Knowledge

• Knowledge of cGMP practices, aseptic techniques, or chemical concepts preferred
• Subject Matter Expert on downstream processing steps

Skills

• Strong math skills
• Critical thinking and problem-solving capabilities
• Detail Oriented
• Results Driven
• Efficient in MS Office
• Qualified to train other employees preferred

Abilities

• Critical evaluation of processes, including foresight and thinking ahead
• Able to read, write, and communicate in English
• Able to understand and carry out instructions
• Reliable
• Effectively multi-task
• Able to work in an environment of change
• Able to work independently and as part of a team
• Able to recognize problems developing, not just occurring
• Seeks and welcomes feedback and responds to coaching

Environmental Conditions

• First Shift (Days)
• 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.)
• Second Shift: Rotating 4 10's - 10%
• Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)
• Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
• Able to lift minimum of 25 lbs independently
• Able to stand for 80% of shift