Work Schedule
Other

Environmental Conditions
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.), Standing for full shift

Job Description

About the Role

Are you a skilled Formulation Technician? Thermo Fisher Scientific Inc. is hiring for the role of Formulation Technician II. Join our innovative facility and be part of manufacturing biopharmaceutical products. Your work will be critical in maintaining international quality standards and achieving flawless production execution.

Key Responsibilities

• Complete Unit Operations: Carry out various unit operations, manual tasks, and measurements in a clean room setting following cGMP guidelines.
• Maintain Production Suites: Contribute to the overall departmental responsibility for keeping production suites in outstanding condition, including 5S initiatives and Fit & Finish inspections.
• GMP Documentation: Ensure GMP documentation is meticulously filled in during production and make required corrections in a timely manner as per cGMP guidelines.
• Equipment Maintenance: Take ownership of equipment maintenance, ensuring it is completed appropriately and on schedule. Maintain documentation and calibration, and serve as a troubleshooter and knowledgeable user.
• Documentation: Revise, assist in the review, and write necessary documentation. Implement corrective or preventive actions at the execution level.
• Support New Procedures: Assist in the support and implementation of new procedures and/or equipment in the OPS department.
• Problem Solving: Signal problems and communicate effectively to the responsible person.
• Validation Protocols: Help in completing validation protocols that require Technician II DSP technical skills.
• Training: Train co-workers on unfamiliar unit operations or equipment, including approving on-the-job trainings.
• Compliance: Ensure all activities are driven in accordance with cGMP Quality System and Thermo Fisher EH&S requirements.
• Miscellaneous Tasks: Perform other miscellaneous office tasks as needed.

• Educational Background: Minimum MBO level education in Biotechnology, Process Technology, or a related field.
• Relevant Experience: Completed MBO in a relevant field or equivalent education.
• Technical Knowledge: Proficiency in relevant process unit operations such as chromatography, filtration, or UF/DF.

• Problem Analysis: Ability to analyze and solve complex problems efficiently.
• Cooperative: Strong teamwork and collaboration skills.
• Planning and Organization: Outstanding organizational and planning abilities.
• Integrity: High level of integrity and ethical standards.
• Subject area: Showing a dedicated approach to following protocols and procedures.
• Quality Orientation: Persistence in maintaining high-quality standards.
• Result Orientation: Committed to achieving outstanding results.
• Communication Skills: Excellent verbal and written communication abilities.
• Flexibility: Adaptability to varying tasks and working hours.