Upstream Processing Technician II

Job Description

***NIGHT SHIFT***

Job Title: Upstream Processing Technician II

Location/Division Specific Information

St. Louis, MO/ Drug Substance Division (Biologics)

Discover Impactful Work:

The candidate will help the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture). These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), and conducting large scale filtration or centrifugation.

A day in the Life:

Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.

Assist in 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. Complete document reviews and revisions. Daily record review, tasks, and databases.

Participate/Lead in shift exchanges, 1-1’s, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities).

Support a quality investigation by answering questions and making suggestions for improvement.

Practices and promotes safe work habits and adheres to safety procedures and guidelines.

Critical evaluation of processes, including foresight and thinking ahead.

Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly.

Keys to Success:

Education:

HS Diploma/ GED required, 0-4 years’ experience required based on education

Experience:

Experience in manufacturing and/or GMP environment preferred

Knowledge, Skills, Abilities

Knowledge

Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred

Skills

Critical thinking and problem solving

Strong math skills

Detail oriented

MS Office

Abilities

Able to demonstrate practical knowledge with successful outcomes

Able to recognize problems developing, not just occurring

Able to read, write, and communicate in English

Able to understand and carry out instructions

Reliable

Effectively multi-task

Can work in an environment of change

Work independently and as part of a team

Physical Requirements / Work Environment

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

Ability to lift minimum of 25 lbs independently

Ability to stand for 80% of shift

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer a company culture that stands for integrity, intensity, involvement, and innovation!