Senior Manufacturing Technician Role at Thermo Fisher Scientific
Environmental Conditions and Safety Standards
Adherence to Good Manufacturing Practices (GMP) safety standards is essential. Cleanroom requirements include no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair. Authorized personnel may work in cold rooms/freezers at -22°F/-6°C, office areas, and designated personal protective equipment (PPE) zones. The role involves working with hazardous/toxic materials.
Work Schedule and Rotating Shifts
This 12-hour rotating shift position requires a 12-hour daily commitment. The schedule allows for flexibility while maintaining high productivity levels.
Job Overview and Responsibilities
As a Senior Manufacturing Technician at Thermo Fisher Scientific, you will play a pivotal role in ensuring the highest quality standards are met. This includes maintaining detailed production processes, supporting scientific innovation, and contributing to the company's mission.
Key Responsibilities:
1. Setup and operation of pharmaceutical production equipment, including high-speed filling lines for sterile products, autoclaves, washers, depyrogenation tunnels, formulation processes, HMI, CIP/SIP processes, and inspection and packaging line equipment, following standard operating procedures (SOPs) and batch records.
2. Completion of formulation activities, including dispensing drug substances and excipients.
3. Preparation, washing, and sterilization of materials and parts.
4. Handling packaging and transfer of final products to freezers.
5. Completion of necessary training prior to task execution.
6. Performance of all transactions at each manufacturing step using SAP.
7. Adherence to aseptic techniques and practices for aseptic operations.
8. Maintenance and cleaning of production equipment and classified areas.
9. Conducting routine QC sampling and in-process testing.
10. Completion of batch records and logbooks in compliance with GDP.
11. Transfer of materials for batch manufacturing.
12. Preparation of filters for testing and performance of FIT (Filter Integrity Testing).
13. Loading and unloading equipment during production activities.
14. Monitoring stock levels and informing management of material requirements.
15. Ensuring safety and quality compliance, reporting anomalies promptly.
16. Participation in EHS, Business Compliance, cGMP, and other activities.
17. Reporting quality issues immediately.
18. Performance of microbial sampling and swabbing if required.
19. Liaising with vendors for calibration and maintenance.
20. Conducting calculations for product potency and endotoxin levels if necessary.
21. Inspection, labeling, and packaging of finished products, and performance of in-process sampling and inspections.
22. Undertaking additional duties as assigned.
Qualifications and Skills
* Minimum 'O' Level, NITEC/ITE diploma, or relevant field education.
* 3-5 years of relevant pharmaceutical industry experience.
Required Skills and Abilities
* Good understanding of safe working practices and cGMP.
* Motivation to work in the pharmaceutical industry.
* Strong team-player with ability to work rotating shifts.
Additional Details
* Seniority level: Not Applicable.
* Employment type: Full-time.
* Job function: Production, Supply Chain, and Manufacturing.
* Industries: Pharmaceutical Manufacturing and Biotechnology Research.