Lead Formulation Technician

Work Schedule

Second Shift (Afternoons)

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, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Job Title:

Downstream Processing Lead Technician IV

Location/Division Specific Information

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

Are you ready to take your career in manufacturing to the next level? Thermo Fisher Scientific Inc. is currently seeking a highly skilled and motivated Downstream Processing Technician IV to join our world-class team in St. Louis. As a leading company in the scientific research industry, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer.

In this role, you will have the opportunity to work with a team of exceptional professionals and play a vital role in the flawless execution of manufacturing batch records, work instructions, and SOPs. Your keen attention to detail and proactive approach will ensure that all tasks are completed right the first time. Additionally, you will assist in maintaining the suite, supplies, equipment, logbooks, and data to strict cGMP standards, contributing to the success of our manufacturing operations.

A day in the Life:

* 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.

Keys to Success:

Education:

* Required:

High school diploma or equivalent

* Preferred:
Associates Degree w/ +2 years of relevant years of experience or Bachelor's degree

Experience:

* Required:

Minimum of 4 years experience in a manufacturing, operations, production, lab setting or related field

* Preferred:
Experience in a cGMP environment

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

* Qualified to train (preferred) and guide employees.

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…