About our client: Our client is a growing CRDM organization specialized in biologics drug development.
*This role will be hired on a renewable contract basis to support our client's ongoing project.
Work Location: Tuas
About the role:
About the role: The Electrical & Instrumentation Engineer oversees the design, installation, commissioning, and qualification of process and utility electrical and instrumentation for projects. These include ensuring adherence to agreed objectives such as budget, time schedule, and functionality under URS, cGMP, safety, and environmental requirements. Additionally, the Electrical & Instrumentation Engineer transitions into operational phases post-project, ensuring seamless integration and functionality of electrical and instrumentation systems.
Responsibilities:
Design Phase
- l Develop electrical and instrumentation specifications based on project requirements and standards.
- l Involve or conduct feasibility studies, instrument criticality and risk assessments for instrumentation and electrical systems
- l Develop and maintains various engineering documents such as project instrumentation specifications & instrument catalogue, preferred vendors list, specifications, equipment list, layouts, etc.
- l Evaluate and specify instruments and electric devices designed for process & utility applications
- l Creates and maintains instrument objects and datasheets and loop diagrams in the project database
- l Supports procurement process with technical expertise
- l Reviews and approves process data and PID’s with E&I-specific knowledge
- l Collaborate with other engineering disciplines to ensure integrated designs. Review and approve design documents, drawings, and calculations.
- l Responsible of procurement by developing URS for purchase and leading/support bidding process including inspection of equipment and materials
Installation / Qualification Phase
- l As a start-up team member, participate, supervise and coordinate in the installation, commissioning & qualification for electrical and instrumentation.
- l Working with the Qualification team & user QA team to prepare and maintain the documents for the Commissioning & Qualification of the instrumentation. Ensure compliance with design specifications, codes, and standards during installation
- l Supports and arranges calibration activities on site before commissioning, qualification or handover to operational
- l Manage contractors and subcontractors involved in installation activities.
- l Review, support or develop commissioning plans, qualification protocols and procedures for electrical and instrumentation systems.
- l Conduct pre-commissioning checks and inspections.
- l Perform or oversee the functional testing of electrical equipment, control systems, and instrumentation devices.
- l Troubleshoot and resolve commissioning issues and discrepancies.
- l Support or execute qualification tests and inspections according to approved protocols. Document qualification results and deviations, and ensure compliance with validation requirements.
- l Review qualification reports and support final approval processes.
- l Coordinate with operations and maintenance teams for system handover.
Operational Phase
- l Responsible for researching and selecting appropriate master calibrators for various instruments used in the workshop. These calibrators serve as reference standards to ensure the accuracy of measuring instruments.
- l Responsible for setting up calibration workshop, procure and maintain standard calibration equipment such as multimeters, temperature and pressure calibrators, signal generator, Mass and Weight Calibrators, etc., needed to perform calibrations accurately as per procedures.
- l Collaborate with all stakeholders to ensure smooth transition and startup of electrical and instrumentation systems.
- l Provide training and support to team members and maintenance personnel on system functionalities and procedures and compliance with relevant standards.
- l Create and maintain a plan/list of all instruments requiring calibration in the workshop and field. This plan/list should include information such as instrument type, serial number, calibration due dates, and historical calibration data within the Maximo system.
- l Establish a calibration schedule based on instrument types, usage frequency, manufacturer recommendations, and regulatory requirements to ensure timely calibrations and compliance.
- l Develop and document detailed calibration procedures for different types of instruments used in the workshop or field. This includes specifying calibration intervals, measurement tolerances, and calibration methods as per compliance requirements.
- l Setup up process to deal with any calibration issues (out of range and/or instrument failures)
- l Monitor system performance and reliability during initial operational phases.
- l Participate in continuous improvement initiatives and implement
- l design changes as needed based on operational feedback.
About you:
- Bachelor’s degree or above in engineering, mechatronics or related
- Over 8 years of working experience in the pharmaceutical / Life Science / Biologics industry
- Professional experience in design and project management skill including budgeting and scheduling
- Expert from design Institute within a pharmaceutical direction and engineering company, or chief engineer of a pharmaceutical company and equipment manufacturer.
- Instrumentation experiences in Biotech/or production
- Familiar with computerized maintenance system (eg Maximo or others)
- Candidates with a combination of instrumentation (Primary) knowledge and automation (Secondary) expertise will be preferred
- Ability to work under pressure, ability to assert oneself, fast decision making, high flexibility
- Demonstrated ability to engage with internal and/or external auditors on instrumentation-related matters and ensure prompt follow-up on CAPA (Corrective and Preventive Actions) actions post-audit.
- Familiar with office software, AUTOCAD and other necessary software
- Good cooperation and communication skills, accept short-term business travel in domestic and international.
- Able to travel for overseas trainings (up to 3 months)
- Knowledge of regulatory standards and codes
*Please note that only shortlisted candidates will be contacted.
EA Name: Kingsforce Management Services Pte. Ltd.
EA License 94C3545
EAP Name: Paola Jane Ofrasio Fajardo
EAP Reg No: R1325507
