Lead Technician, Production Support (ECA)

Work Schedule

12 hr 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), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:
St. Louis, MO/ Drug Substance Division (Biologics)

Work Schedule:

12-hour shift 6am - 6:30pm on a rotating 2-2-3 schedule

How Will You Make an Impact:
The candidate will lead performance of operations in support of the manufacture of Commercial and Clinical Biologics. As Lead Technician, your keen attention to detail and proactive approach will ensure that all tasks are completed right the first time. You will be leading a Team in a variety of functions related to cleaning of primary, secondary, and ancillary equipment, assembly of manufacturing tanks, vessels, and line assemblies.

A Day in the Life:

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

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

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

• Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations

• 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 documentation in appropriate systems

• Complete validation protocols with minimal supervision or direction

• Represent manufacturing team at tier meetings, as needed

• 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 procedures

• Maintain safe and clean work environment by educating and leading personnel to ensure compliance with established policies and procedures

• Actively participate in shift exchanges, 1-1 meetings, including attending meetings as required to facilitate our needs based on changes (lean activities)

• Provides training as a qualified trainer with team either in class or on the floor

• Help build cross-functional relationships and improve relationships with team members

• Provides frequent feedback and mentor to others on ways to improve performance

• Complete production plan by scheduling and assigning personnel, prioritizing tasks, leading progress, resolving problems, and reporting results

• Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization

Education:
High school diploma or equivalent required.

Experience:

• 3 - 5 years of meaningful work experience required
• Experience in cGMP environment or aseptic manufacturing, preferred

Knowledge, Skills, Abilities:

Knowledge

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

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

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