Job Summary：
The Electrical & Instrumentation Engineer key role in overseeing the design, installation, commissioning, and qualification of process and utility electrical and instrumentation for projects. Responsibilities include ensuring adherence to agreed objectives such as budget, time schedule, and functionality in accordance with 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.
Job Content：
Design Phase
- Develop electrical and instrumentation specifications based on project requirements and standards.
- Involve or conduct feasibility studies, instrument criticality and risk assessments for instrumentation and electrical systems.
- Develop and maintains various engineering documents such as project instrumentation specifications & instrument catalogue, preferred vendors list, specifications, equipment list, layouts, etc.
- Evaluates and specifies instruments and electric devices designed for process & utility applications.
- Creates and maintains instrument objects and datasheets and loop diagrams in project database.
- Supports procurement process with technical expertise.
- Reviews and approves process data and PID’s with E&I specific knowledge.
- Collaborate with other engineering disciplines to ensure integrated designs. Review and approve design documents, drawings, and calculations.
- Responsible of procurement by developing URS for purchase and leading/support bidding process including inspection of equipment and materials.
Installation / Qualification Phase
- As a member of the start-up team, participate, supervise and coordinate in the installation, commissioning & qualification for electrical and instrumentation.
- Working together with the Qualification team & user QA team for preparation and maintaining of the documents for the Commissioning & Qualification of the instrumentation. Ensure compliance with design specifications, codes, and standards during installation.
- Supports and arrange calibration activities on site prior to commissioning, qualification or handover to operational.
- Manage contractors and subcontractors involved in installation activities.
- Review, support or develop commissioning plans, qualification protocols and procedures for electrical and instrumentation systems.
- Conduct pre-commissioning checks and inspections.
- Perform or oversee the functional testing of electrical equipment, control systems, and instrumentation devices.
- Troubleshoot and resolve commissioning issues and discrepancies.
- Support or execute qualification tests and inspections according to approved protocols. Document qualification results and deviations, and ensure compliance with validation requirements.
- Review qualification reports and support final approval processes.
- Coordinate with operations and maintenance teams for system handover.
Transition into Operational Phase
- Responsible to research and select appropriate master calibrators for various instruments used in the workshop. These calibrators serve as reference standards to ensure the accuracy of measuring instruments.
- Responsible to set up calibration workshop, procure and maintain standard calibration equipment such as multimeters, temperature and pressure calibrator, signal generator, Mass and Weight Calibrators, etc., needed to perform calibrations accurately as per procedures.
- Collaborate with all stakeholders to ensure smooth transition and startup of electrical and instrumentation systems.
- Provide training and support to team members and maintenance personnel on system functionalities and procedures and compliance with relevant standards.
- 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.
- Establish a calibration schedule based on instrument types, usage frequency, manufacturer recommendations, and regulatory requirements to ensure timely calibrations and compliance.
- 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.
- Setup up process to deal with any calibration issues (out of range and/or instrument failures)
- Monitor system performance and reliability during initial operational phases.
- Participate in continuous improvement initiatives and implement.
- Design changes as needed based on operational feedback.
Requirements：
- Bachelor degree or above in engineering, mechatronics or related
- Over 8 years working experience in relevant industry
- Professional experience in design and project management skill including budgeting and scheduling
- Expert from design Institute within pharmaceutical direction and engineering company, or chief engineer of 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.
Other Special Requirements：
- No significant observations in external regulatory inspections for areas of control.
- No significant HSE incidents in the execution of FAT, SAT and subsequent commissioning and qualification phases.
- Achieving OQ completion of final critical path system within + / - 2 weeks of final baseline schedule
- Automation delivered with minimal re-work / disruption in post OQ activities (resulting from latent deficiencies from the project delivery phases)
- Self-initiative, independent and goal-oriented way of working.
- Familiar with office software, AUTOCAD and others necessary software
- Good cooperation and communication skills, accept short term business travel in domestic and international.
- Is able to go for minimum 3 months training in China.
- Knowledge of regulatory standards and codes
- Proficiency in the Chinese/English languages will confer an advantage in terms of facilitating effective communication with counterparts and stakeholders.