Formulation Technician II

at  Thermo Fisher Scientific

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.

• 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.