Senior TS Engineer 2

Project Scope:

• Review and approve equipment utilities design and process equipment design.

• Review, execute and approve FAT/SAT protocol

• Execute task on equipment mechanical completion

• Execute task on IOQ protocol and review IOQ report

• Draft, review and approve URS/CIA/SOP

• Review and approve maintenance plan, procedure, spare parts and maintenance frequency

• Support process equipment PQ and cleanroom PQ

Routine Maintenance Scope:

• Lead a team of technicians responsible for the smooth operation and maintenance of systems, equipment and processes to minimize downtime and ensure system and equipment performance comply with cGMP, EHS and GEP requirements and able to operate at optimal condition, meeting TS and business expectation.

• These engineers oversee the work of their teams. They are expected to demonstrate leadership behavior by coaching and developing others, share accountability and collaborate with strong teamwork for continuously improvement.

1. Utility

Responsible and manage team for the operation and maintenance of utility systems to provide the required level of availability.

• Ensure all utility systems operate smoothly and delivers the required level of reliability, availability and quality.

Utility System

Black utility system:

• Cooling Tower

• Steam Boiler

• MVAC Boiler

• Glycol Chillers

• Air Compressors

• Air Dryer

• Liquid Nitrogen Package

• Trigeneration

Clean utility system:

• Purified Water Generation

• Purified Water Storage and Distribution

• Water-for-Injection Generation

• Water-for-Injection Storage and Distribution

• Pure Steam Generation and Distribution

• Technical Gases

• Manage teams for all routine repair and maintenance activities are completed on schedule.

• Manage teams to develop, implement and execute maintenance programs using SAP and other maintenance best practices/ tools in a safe and cost-effective manner and in compliance with requirements.

2. Automation

Ensure automation system operate smoothly and deliver the required reliability and availability level.

• Ensure automation system operate smoothly and deliver the required reliability and availability level.

• Manage teams to support all routine planned maintenance activities under the automation team are completed on schedule.

• Manage teams to complete any breakdown repair, troubleshooting and ensuring corrective action/ preventive action (CAPA) is in place to eliminate similar breakdown.

• Work with cross functional teams in routine cGMP equipment/ system to re-qualification on activities.

• Manage automation system related SMR/RPC plans.

• Performance monitoring of automation system.

• Execution of business recover plan.

Site automation system comprises of the following:

• Process Control System (PCS)

• Automated and Analytical System (AAS)

• Automated and Analytical Workstation (AAW)

• Particle and Environment Monitoring System (PEMS)

• Alarm Management System (AMS)

• Warehouse Environmental Monitoring System (Oceansoft)

• Building Management System (BMS)

• Card Access System, Intercom System, Master Clock System, CCTV System and PA System (LCS)

• MPMS Infrastructure and Network Components (MPMS infrastructure)

• Emergency Shutdown System (ESD)

3. HVAC

Responsible and manage team for the operation and maintenance of HVAC and Clean Room systems to provide the required level of availability.

• Ensure all HVAC and cleanroom systems operate smoothly and delivers the required level of reliability, availability and quality.

• Ensure all routine repair and maintenance activities are completed on schedule.

• Manage teams to develop, implement and execute maintenance programs using SAP and other maintenance best practices/ tools in a safe and cost-effective manner.

• Manage and/or support related CAPA, validation, Lean and quality related matters.

• Manage teams to maintain, calibrate and perform qualification for plant equipment to maximize plant availability and minimize disruption to production.

4. Project

Support organization operations on CAPA projects / engineering change modification execution to meet users’ requirement. Plan, control and monitor project schedule with resource and procurement planning.

• Manage teams to collaborate with cross functional departments on CAPEX projects or change modification (SMR/RPC) implementation.

• Manage contractors / external service providers for performance to meet project delivery.

• Ensure teams execute IQ & OQ phases of new projects and ensure proper hand over of completed project’s documents and drawings.

• Provide support in submission and obtaining the approval of required local permits / licence for new engineering project / modification installation.

5. Facility

Manage team to carry out site facilities / buildings maintenance and general site checking and services in partnership with external service providers to ensure all facilities and building are compliance and safe.

• Ensure timely execution of site facilities / buildings maintenance work, landscaping, cleaning services, cafeteria.

• Ensure teams can work with cross functional members and service providers to carry out site facilities inspections with relevant agencies and prepare site facilities for visitors’ visit.

6. Validation

Manage team in engineering qualification and validation life cycle support (excluding Automation / Computer System) to meet cGMP, GSK guidelines / policies, site procedures and regulatory guidance by ensuring all new engineering CAPEX / Modification is performed according to the Validation / Commissioning master plan and User Requirement Specifications.

• Work with QA Validation and users to define the validation approach for the existing and / or newly installed equipment.

• Together with QA, Product Transfer team and users on Leachable and Extractable to study and analyse for new equipment installed.

• Work with TS team and external resources on functional / design specification study and qualification activities for temperature mapping till PQ phase.

7. TS Support & Continuous Improvement

CAPA Management and Planning

• Manage teams to report deviation and determine CAPA actions.

• Track and monitor CAPA closure.

• Track and monitor department’s leave / OT / MC rate to ensure daily tasks are not impacted.

Operation and Cost

• Oversees that all administrative works are duty carried out in support of TS operation.

• Plan and manage company transport to ensure safety, cost effective and reliable.

• Track and monitor Opex and Capex spending is within budget and enforce all invoices are received for all jobs done.

• Ensure TS operations are up and well running.

Training and Development

• Plan and develop working knowledge for continuous improvement of the teams in TS.

• Oversees TS training function to ensure staff are competent to perform their tasks effectively and efficiently.

8. Reliability

Assure reliability of plant equipment and systems by managing team to implement conditioning monitoring and methods, conduct equipment measurement and improvement on repeating failure; evaluate/analyze data/results, provide recommendation and follow up monitoring.

• Identify in-process equipment / system conditions by collecting, classifying, analyzing, and interpreting condition base monitoring data (eg. Vibration, alignment, oil analysis, ultrasonic gauging)

• Assess equipment reliability / acceptability in comparison to specifications.

• Determine acceptability of equipment rework / installation by conducting assessment and physical check / test of reworked equipment or new installation job.

• Update equipment conditioning monitoring database.

Maintain equipment reliability operations by following equipment reliability / maintenance excellent and procedures; notifying any equipment defect and deterioration conditions that requires the attention of maintenance team or relevant parties.

9. Electrical

Assure all electrical switchboards, power supply panels for process plants equipment and utilities area are always well maintained for maximum plant availability. Manage team to perform the following:

• Maintain all electrically driver equipment to maximize plant availability and minimize disruption to the production process.

• Provide effective solution to troubleshooting work on all electrically driven equipment.

• Ensure all HT, LV and MV switchboards are always in good conditions so as to minimize disruption to the production process.

10. Mechanical

Manage team to maintain and calibrate plant equipment and in qualification state for maximum plant availability at all times.

• Ensure availability of plant assets to prevent production downtime.

• Ensure all routine planned maintenance, calibration, routine planned repair / replacement and maintenance activities under maintenance team are completed on schedule.

• Provide support to new project construction and commissioning activities.

11. SAP/ Planning

• Manage Master Data base in SAP for MRO, Calibration & Measurement (C&M) and Plant Maintenance (PM) modules for all entries of plant equipment, buildings and assets. Ensure Master Data is current and compliance with the Global Biologicals C&M and Maintenance practice & requirement

12. Others

• Be a team player and spearhead in events.

• Any other duties as assign by the supervisor

13. Quality

• Ensure proper good documentation and record system to ensure quality assurance operations.

• Ensure Corrective Action / Preventive Action (CAPA) is in place to eliminate quality related deviation.

• Ensure audit readiness.

• Comply with all relevant site SOPs, global SOPs, GEP and GDP.

14. Management

• Facilitate team growth through continuous career development.

• Manage team performance for timely completion of jobs.

• Accomplish staff results by communicating job expectations, appraisal of job results, coaching of employee, complying with goal requirements, enforcing on policies and procedures.

15. Safety

• Comply with site and global EHS and Biosafety procedures.

• Ensure all related work activities are carried out according to site SEHS policies and procedures.

• Provide a safe environment by complying to all essential statutory and cooperate requirement to protect the employees, equipment and environment.

16. Planning

• Plan, coordinate and execute day to day activities.

• Ensure completion of all works according to plan and schedules.

17. Costs

• Achieve financial objectives by monitoring and control expenditures within allocated budget.

• Contribute to cost management effort by accomplishing related results as needed.

• Provide cost-effective solutions in the upkeep and enhancement of plant asset life.

18. Continuous Improvement

• Drive continuous improvement by providing recommendation and initiative to promote sustainability.

• Min Degree in chemical engineering

• Min 4 years of engineering experience

• Min 2 years of technical experience in Bio/Pharm Industry

• Highly knowledgeable and competent in their field of work.

• Strong technical knowledge and well verse in all technical aspects.

• Demonstrate excellent GMP behaviour and safe practices.

• Substantial fault-finding and trouble-shooting experience.

• Strong leadership in team management.

• Good analytical skill in investigation.

• Lead complex issues investigation and detailed troubleshooting.

• Good interpersonal skills.

• Good oral and communication skills.

• Customer focus and result oriented.

• Good people management and coaching skills.

• Good teamwork.

• A strong leader and think out of the box.

• Excellent regulatory knowledge.

• Integrity and Innovative.

• Problem solving skill.

• Analytical thinking skill.

• Facilitation and organization skill.

• Good time management.

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