Senior Engineer, Manufacturing Engineering

at  Thermo Fisher Scientific

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Discover Impactful Work:
Responsible to maintain the equipment and utilities in the same state as it was qualified. Collaborate with a multi-functional team to meet production and quality goals.

A day in the Life:

• Review equipment system design, Factory Acceptance Test (FAT), installation/ Site Acceptance Test (SAT) commissioning/ validation.
• Coordinate maintenance activities, includes prevention maintenance, corrective maintenance and spare part management.
• Supplier management, external maintenance third party vendor management.
• Create and update SOP/WI and other operation documentation. Ensure department GMP procedures are in compliance with relevant company policies and regulatory requirements.
• Facilitate execution of quality deviation, change control and corrective and preventive action (CAPA) etc.
• Act as clean utilities and HVAC SME in regulatory audit or customer audit.
• Own the maintenance related OPEX budget, lead and implement the site driven projects, handling subcontractors for successful execution
• Implementing site wide EHS procedures for maintenance activities and actively drive safety & quality culture.

EDUCATION

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• Bachelor of Engineering with shown ability.

EXPERIENCE

• Good knowledge in GMP, clean utilities, HVAC and Data integrity in a sterile manufacturing environment.

KNOWLEDGE, SKILLS, ABILITIES

• Shown knowledge on equipment maintenance, preventive maintenance and spare part management.
• Experience on equipment package CQV (commissioning, qualification and validation) is helpful.

Please refer the Job description for details