Formulation Technician II

Make it in the North; Groningen; Hybrid; EUR 32,000 - 45,000; Full time

Benefits offered by this job

Competitive Pay

Performance Related Bonus

Annual merit increase

Excellent Benefits

Medical benefits

Paid Time Off/Annual Leave

Employee Referral Bonus

Career Advancement Opportunities

Job summary

Thermo Fisher Scientific in Groningen seeks a Technician II DSP to perform unit operations and measurements in a clean room under cGMP. You will ensure proper GMP documentation, participate in equipment maintenance, and support validation activities within the OPS department.

The role requires knowledge of chromatography, filtration, or UF/DF, and a willingness to train teammates on procedures and equipment, all while adhering to safety and EH&S standards.

Qualifications

• Minimum MBO level in Biotechnology or Process Technology.
• Knowledge of unit operations such as chromatography, filtration or UF/DF.
• Experience working under cGMP/cGMP conditions and in clean room settings.

Responsibilities

• Execute unit operations, manual operations and measurements in a clean room under cGMP.
• Maintain production suites with 5S and inspection routines.
• Ensure GMP documentation is completed and accurate.
• Implement corrective/preventive actions at execution level.
• Assist in training coworkers on unit operations and equipment.
• Support validation protocols requiring DSP technical skills.
• Maintain and calibrate equipment and uphold EH&S requirements.

Skills

Unit operations knowledge

GMP/cGMP familiarity

Troubleshooting skills

Documentation accuracy

Education

MBO level in Biotechnology or Process Technology

Tools

Calibration & maintenance

Job description

The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications.

This type of facility has to comply with rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulations.

The production activities have to be executed in an efficient and effective manner to assure the sites overall competitiveness. In addition, due to the very high value of intermediates and products, production activities have to be executed in a highly controlled fashion.

Controlled production activities and compliance to cGMP rules, regulations and guidelines is essential for the suitability of the clients’ products and the license to operate for the site. Main contacts are within own department.

Responsibilities:

• Executes several unit operations, manual operations and measurements, conform the applicable production and standard operating instructions, in a clean room environment under cGMP conditions.
• Contributes to the overall departmental responsibility for the production under GMP conditions of biopharmaceutical products and intermediates, including maintaining the production suites in proper condition (e.g. working on 5S, performing Fit & Finish inspections).
• Ensures GMP documentation is properly filled in during production as required by cGMP.
• Makes sure that required corrections in cGMP documentation, as required by qualified reviewers or supervisors, are made in a timely manner and in compliance with cGMP.
• Contributes to the departmental responsibility for equipment (related to technical skill of Technician II DSP) to assure that maintenance, maintaining documentation and calibration are executed 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 DSP 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 executed within the department in compliance with cGMP Quality System and the Thermo Fisher EH&S requirements.
• Other miscellaneous office tasks.

Requirements:

• Minimal MBO level (e.g. Biotechnology, Process technology).
• Knowledge of relevant process unit operations (e.g. chromatography, filtration or UF/DF).

What We Offer:

• Competitive Pay
• Performance Related Bonus where eligible
• Annual merit performance-based increase
• Excellent Benefits
• Medical benefits
• Paid Time Off/Annual Leave
• Employee Referral Bonus
• Career Advancement Opportunities