Senior Equipment Engineer Role at Thermo Fisher Scientific
We are seeking an experienced Senior Equipment Engineer to join our team in Singapore.
Job Responsibilities:
* Review and assess equipment system design, factory acceptance testing (FAT), site acceptance testing (SAT), installation, validation, and IQ/OQ processes to ensure compliance with regulatory requirements.
* Coordinate maintenance activities including preventive maintenance, corrective action management, and calibration procedures to minimize downtime and optimize equipment performance.
* Manage the Maximo system as an administrator, ensuring accurate tracking and reporting of maintenance activities, spare parts inventory, and other operational data.
* Oversee supplier and third-party vendor management, developing and maintaining relationships to ensure timely delivery of high-quality equipment and services.
* Create and update standard operating procedures (SOPs) and other operational documentation to ensure Good Manufacturing Practice (GMP) compliance and adherence to regulatory requirements.
* Facilitate quality deviation, change control, and corrective action process (CAPA) procedures to identify and address potential issues promptly.
* Act as a subject matter expert during regulatory and customer audits, providing technical guidance and support to ensure compliance and satisfaction.
* Lead maintenance-related budgets and site projects, managing subcontractors and ensuring timely completion within budget and scope.
* Implement site-wide environmental health and safety (EHS) procedures and promote a safety and quality culture, ensuring compliance with regulatory requirements and company policies.
Minimum Requirements:
* Bachelor of Engineering degree from an accredited institution.
* Strong knowledge of GMP, clean rooms, HVAC systems, data integrity, and digitalization in sterile manufacturing environments.
* Experience in equipment maintenance, preventive maintenance, and spare parts management, with a proven track record of minimizing downtime and optimizing equipment performance.
Preferred Skills:
* Experience with commissioning, qualification, and validation (CQV) processes, including development and execution of CQV protocols.
* Operational excellence, lean methodologies, and energy-saving initiatives, with a focus on continuous improvement and efficiency gains.
Additional Information:
* This is a full-time position offering competitive benefits and opportunities for professional growth and development.
* The selected candidate will work in a GMP-compliant environment, adhering to strict cleanroom protocols and wearing personal protective equipment (PPE) as required.