Formulation Technician II

Work Schedule

Other

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), No eye contacts allowed; prescriptive glasses will be provided, 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.), Will work with hazardous/toxic materials

Job Description

Key Areas of accountability/responsibility

• Performs several unit operations, manual operations and measurements, conform the applicable production and standard operating instructions, in a clean room environment under cGMP conditions.
• Provides to the overall departmental responsibility for the production under GMP conditions of biopharmaceutical products and intermediates, including maintaining the production suites in good condition (e.g. working on 5S, performing Fit & Finish inspections).
• Ensures GMP documentation is accurately filled in during production as needed by cGMP.
• Makes sure that required corrections in cGMP documentation, when observed by qualified reviewers or supervisors, are made in a timely manner and in compliance with cGMP.
• Plays a part in the departmental responsibility for equipment (related to technical skill of Technician II USP) to assure that maintenance, maintaining documentation and calibration are driven in an adequate and timely fashion, acts as trouble shooter and expert user.
• Revises, assists in review and writes documentation.
• Implements corrective or preventive actions on execution level.
• Support and implementation of new procedures and/or equipment in the OPS department.
• Signals problems and communicates to the responsible person.
• Assists in execution of validation protocols for which a Technician II USP technical skill is required.
• Trains co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
• All activities should be driven within the department in compliance with cGMP Quality System and the Thermo Fisher EH&S requirements.

Authorities

NA

Complexity of the Job

• The Thermo Fisher site in Groningen manufactures many products for clinical trials and commercial applications. This implies that the production activities range from driving a totally new production run for the first time, to the routine production of a commercial batch.
• Due to the diversity of costumers, and their associated products, the applicable processing steps are very diverse.
• Given the high value of the products and intermediates the Technician II USP has to work accurately and optimally and in agreement with cGMP and EH&S.
• Due to involvement in the timely execution of manufacturing processes under cGMP conditions, a fair amount of strictness and flexibility in working hours are required.
• The job of a technician II mostly interacts within the USP team and occasionally requires interaction with the MSAT and Quality assurance team.

Knowledge and educational level

• Minimal MBO level (e.g. Biotechnology, Process technology).
• Knowledge of relevant process unit operations (e.g. Cell culture, Bioreactors or Cell banking).

Required Level of Experiences

• Completed MBO in relevant field, or equivalent education.

Competences

• Standout colleague
• Integrity
• Strictness
• Quality oriented
• Result driven
• Verbal communication
• Written communication
• Flexibility