CASY-MSCCN Jobs

Work Schedule

Other

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

What sets this opportunity apart

Join our world-class team at Thermo Fisher Scientific Inc. in Groningen, where you will have the opportunity to contribute to groundbreaking biopharmaceutical production. Our ambitious and diverse team strictly adheres to cGMP standards to deliver outstanding products that have a tangible impact on global health.

Key Areas of Accountability/Responsibility

• Complete various unit operations, manual processes, and measurements in a clean room environment following cGMP guidelines.

• Contribute to departmental responsibilities for biopharmaceutical production under GMP conditions, including maintaining production suites (e.g., working on 5S, performing Fit & Finish inspections).

• Ensure flawless GMP documentation during production as required by cGMP.

• Make required corrections in GMP documentation promptly, as directed by qualified reviewers or supervisors, and in compliance with cGMP.

• Maintain and calibrate equipment related to the technical skills of a Technician II DSP, acting as a troubleshooter and expert user.

• Revise, assist in reviewing, and write documentation.

• Implement corrective or preventive actions at the execution level.

• Support and implement new procedures and equipment within the OPS department.

• Signal problems and communicate them to the responsible person.

• Help complete validation protocols that require Technician II DSP technical skills.

• Train co-workers unfamiliar with certain unit operations or specific equipment, including approval of on-the-job trainings.

• Complete all activities within the department while adhering to the cGMP Quality System and Thermo Fisher EH&S requirements.

• Perform other miscellaneous office tasks.

Complexity of the Job

• The Thermo Fisher site in Groningen manufactures a diverse range of products for clinical trials and commercial applications. This includes completing new production runs and performing routine production of commercial batches.

• The diversity of customers and their products requires a wide range of processing steps.

• Given the high value of products and intermediates, the Technician II DSP must work accurately, reliably, and in agreement with cGMP and EH&S standards.

• Successful completion of manufacturing processes within specified timelines in a cGMP environment requires adaptability and flexibility in working hours.

Knowledge and Educational Level

• Minimum MBO level (e.g., Biotechnology, Process Technology), or equivalent experience.

• Knowledge of relevant process unit operations (e.g., chromatography, filtration, or UF/DF).

Required Level of Experience

• Completed MBO in a relevant field or equivalent education.

Skills

• Problem Analysis

• Cooperative

• Planning and Organization

• Integrity

• Field

• Quality Orientation

• Result Orientation

• Verbal Communication

• Written Communication

• Flexibility

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.