Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Working Location: Joo Koon
Reports to: Manager, Technical Operations
How Will You Make an Impact?
At Thermo Fisher Scientific Inc., you have the opportunity to be part of an extraordinary team that is dedicated to making the world healthier, cleaner, and safer. This position offers an exceptional chance to bring to bear your proven expertise in a dynamic and collaborative environment. As an Engineer III, Manufacturing, you will play a crucial role in driving process improvements, ensuring flawless production activities, and supporting ambitious new product introductions.
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What will you do?
The incumbent provides technical support for all the products manufactured at the site. Responsible for process improvements, cleaning validations, and new product introductions. You will also support validation, qualification activities, and quality investigations.
Responsibilities
- Support NPI (New Product Introduction) by participating and leading development studies, cleaning process development, and qualification activities.
- Demonstrate in-depth knowledge of change controls, cleaning validations, qualifications, and process performance trending and reporting.
- Author technical operations protocols, reports, and other documentation related to existing products or new product introductions.
- Act as a mentor to guide junior engineers in handling NPI, quality investigations, CPV, and problem-solving tools.
- Collaborate with production managers to optimize yields, improve plant flexibility, and minimize costs while adhering to GMP, budget, and safety standards.
- Demonstrate expertise in technical writing for reports, protocols, quality investigations, and change requests.
- Lead significant quality investigations and act as a technical reviewer for change controls.
- Provide technical expertise for day-to-day production activities, including root cause analysis, process improvements, and implementation of new technologies.
- Support quality compliance activities, including documentation updates, change control, investigations, and CAPA.
- Supervise and review CPV and APR activities to monitor and adjust process parameters and equipment performance.
- Ensure continuous improvement in production structure by proposing actions related to plant layout, GMP adaptation, and cost optimization.
- Participate in critical technical projects related to commercial sterile pharmaceuticals' production.
- Serve as the main interface on technical issues between technical operations and customers.
- Ensure robust and efficient transfer of new products/processes into production.
- Participate in project meetings to transpose customer production processes and support the production process improvements.
- Promote EHS safe practices and ensure safety adherence to standards and SOPs.
- Perform any other duties assigned by the manager.
Minium 2 to 5 years of pharmaceutical experience
Knowledge of pharmaceutical manufacturing processes and GMP
Experience in statistical process controls and related tools
Good digital literacy
Knowledge of safety and environmental regulations
Flexibility and leadership skills
Positive relationship skills and attention to detail
Experience in sterile injectable drug production and packaging/visual inspection preferred
Highly motivated to work in the pharmaceutical industry
Ability to work as part of a team