Lead Downstream Processing Technician

Job Title : Downstream Processing 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 :

Education :

HS Diploma / GED required, Bachelor's degree preferred

Experience :

• 0 - 4 years relevant work experience required based on education
• 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
• 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 problems developing, not just occurring
• Seeks and welcomes feedback and responds to coaching.

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

Join Thermo Fisher Scientific and be part of our ambitious team that strives for excellence in everything we do. We are an equal opportunity employer, committed to fostering an inclusive and diverse workforce.

We value the unique perspectives and contributions of all individuals and actively encourage candidates from all backgrounds to apply.

To apply, please visit our career website at

Thermo Fisher Scientific Inc. is an EEO / Affirmative Action Employer and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

If you require any accommodations during the application process due to a disability, please contact us at 1-855-471-2255*.

We are here to support you and ensure that you have an equal opportunity to succeed.

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