Work Schedule

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

Job Description

Team Lead, Production Support (Equipment Cleaning/Assembly)

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

Work Schedule

8-hour shift / days (hours are subject to change related to business needs) ​

Candidate MUST move to a Supervisor role after two years once a position becomes available.

Discover Impactful Work:

The candidate will help 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 cleaning of primary, secondary, and ancillary equipment, and assembly of production related manufacturing tanks, vessels, and line assemblies. Accountable for the Safety, Quality, Delivery, Cost, and Engagement metrics associated with the Production Support department.

A day in the Life:

• Able to complete all Department functions, such as maintaining, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.

• Documentation of all activities to meet cGMP requirements. Daily logbook review, tasks, and databases.

• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine troubleshooting.

• Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling conflicts with one week outlook.

• 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 techniques.

• Act as on the floor lead in absence of the supervisor.

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

• Represent manufacturing team at tier meetings.

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

• Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.

• Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.

• Coordinates training with team either in class or on the floor, as needed.

• Helps build cross-functional relationships and enhances relationships with team members.

• Provides frequent feedback and coaching to others on ways to improve performance.

• Complete production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results.

Keys to Success:

Education:

• HS Diploma/ GED required; bachelor’s degree preferred.

Experience:

• 2 - 6 years relevant work experience required based on education

• Experience in cGMP environment preferred

• Aseptic manufacturing, preferred

Knowledge, Skills, Abilities

Knowledge

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

• Subject Matter Expert on equipment cleaning and assembly processing steps

Skills

• Strong math skills

• Critical thinking and problem-solving capabilities

• Detail Oriented

• Results Driven

• Efficient in MS Office

• Qualified to train 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 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, walk, reach, stoop, kneel and/ or crouch for 80% of the 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!

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.