- Review equipment system design, Factory Acceptance Test (FAT), installation/ Site Acceptance Test (SAT) commissioning/ validation, Installation/Operation Qualification (IOQ).
- Coordinate maintenance activities, includes prevention maintenance, corrective maintenance, spare part management, and calibration management.
- One maximo administrator.
- 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 SME in regulatory audit or customer audit.
- Lead the maintenance related OPEX and CAPEX 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.
Keys to Success:
Education
- Bachelor of Engineering with proven ability.
Experience
- Good knowledge in GMP, Clean rooms, HVAC system, Data integrity, digitalization in a sterile manufacturing environment.
Knowledge, Skills, Abilities
- Proven knowledge on equipment maintenance, preventive maintenance and spare part management.
- Experience on equipment package CQV (commissioning, qualification and validation) is helpful.
- Operation excellence, lean approach, energy saving experience is helpful
