Location: Tuas
Working Hours: Mon-Fri 9am-6pm
1 Year Contract (Renewable and Convertible)
Salary: Up to $8k + PB + Completion Bonus
Our client is a biotechnology pioneer since 1980 and was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
The Utilities engineer will be responsible for ensuring the facility, equipment and systems are maintained in accordance with the detailed design and that GMP qualification is achieved and complied. The engineer will be the Subject Matter Expert (SME) for the Utilities system operations, maintenance and provide technical/expertise to ensure readiness for routine operations.
The engineer shall ensure adherence to standards and good engineering practices. This includes ensuring the design meets the requirements of Manufacturing, Quality, Information Systems, and Engineering groups.
Support development of commissioning and qualification documents to ensure the utilities system is qualified per regulatory requirement. The engineer will have to also be able to independently resolve technical issues, escalate problems, work in teams, and promote sharing of lessons learned.
Responsibilities:
- Lead/ Support continuous improvement for Utilities system operations, maintenance and reliability program.
- Establish metrics that ensure optimal utility operational performance.
- Lead/ Support system owner in Utility Projects - review of Engineering design documentation and associated engineering drawings.
- Lead/ Support Site Acceptance Test (SAT) and commissioning and testing of System to meet the User Specification Requirements (URS).
- Participate in system walk down to ensure reliable operations of utility systems.
Safety and Quality Compliance Management
- Lead/ Support in Audit readiness for regulatory inspections to ensure compliance to all relevant site SOPs, global SOPs, GEP and GDP.
- Provide support to the development, revision, review, and approval of Standard Operating Procedures, Risk Assessment, Preventive maintenance program and Job Plans.
- Lead/ Support deviation investigation and ensure Corrective and Preventive Action (CAPA) is in place to prevent recurrence of similar incident.
- Lead/ Support Change control or change evaluation initiatives for continuous improvement to enable better system reliability and operations.
- Actively practice Organisations Safety Culture
