Work Schedule

Rotational shift nights/weekends

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Discover Impactful Work:

Thermo Fisher Scientific seeks a Lead Manufacturing Technician to help produce Commercial and Clinical Biologics in a GMP facility.

A day in the Life:

Own the execution of routine and non-routine cleaning of operational areas, per work instructions and/or SOPs, with a focus on "right the first time" executions.Maintain supplies, equipment, logbooks, and data in accordance with site SOPs and policies.Lead the assembly and cleaning activities of manufacturing-related equipment per work instructions and/or SOPs.Document all activities to meet cGMP requirements. Perform daily logbook reviews, tasks, and database updates.Complete preventative maintenance and work notifications tasks on time. Conduct equipment testing and routine troubleshooting.Coordinate 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 the absence of the supervisor. Act as a liaison with other groups within the manufacturing organization and as a Subject Matter Expert on various techniques.Participate in shift exchanges, one-on-one meetings, and attend necessary meetings to facilitate area needs based on changes.Practice and promote safe work habits and adhere to safety procedures and guidelines.Provide feedback on document revisions and/or document management, including batch production records and manufacturing procedures.Seek and welcome feedback, and respond to mentoring.

Keys to Success:

Education:

HS Diploma or equivalent experience required; bachelor’s degree or equivalent experience preferred

Experience:

- 0 - 4 years relevant work experience required based on education

Experience in a cGMP environment preferred

Knowledge, Skills, Abilities:

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