The Automation Systems Lead provides technical expertise for automation operation, maintenance and obsolescence management, computerized systems validation process, SDLC documentation management, quality management and continuous improvement of computerized systems. Provides automation team up to date with latest Automation and IT trends and to drive efficiency, harmonization and improvements leveraging on the best practices in the industry and the latest technology.
- Demonstrates and promotes SHE leadership behavior and engages employees at all levels on SHE issues
- Provides Automation/IT technical expertise to automation teams in the management of hardware and software obsolescence, system upgrades and replacement
- Performs the role of subsystem owner of Quality Management System for computerized systems
- Maintains up to date knowledge and understanding of the Quality System applicable to computerized systems. Identifies gaps to guidelines, initiate remediation actions and ensure completion of actions to comply with guidelines.
- Provides computer system validation knowledge and practical implementation methods to automation team for new system installation and obsolescence upgrade/replacement
- Maintains up to date knowledge and understanding of Merck System Development Life Cycle (SDLC) and to guide implementation of the system and generation of the documentation
- Prepares/Approves IQ and OQ qualification and testing documentation, ensuring documentation meets required regulatory standards
- Coaches Automation Engineers to execute automation projects and change control, include management of project schedules, pre- and post-execution reviews, test plans, resource plans, vendor coordination, material purchases
- Provides automation technical expertise and support to Automation Engineers for deviation and operation investigation requiring code and system-level troubleshooting and ensures timely and effective resolution of issues
- Coaches Automation Engineers to develop skills in effective root-cause analysis and troubleshooting techniques (e.g. KT method, error proofing etc), enabling effective resolution of incidents, events, deviations, investigations and fault reports
- Coaches Automation Engineers to support execution of continuous improvement and OE projects intended to increase agility, flow and throughput, and also to reduce cycle time and inventory
- Coaches Automation Engineers to support regulatory inspections, provides technical expertise, and implements corrective actions as required following regulatory inspections and internal audits
- Provides automation technical support for capital, Operation Excellence and any other site projects
- Acts as automation business and/or technical approver for compliance-related documents, including: SOPs, Job Aids, automation training packages, qualification protocols, Automation change controls, incident reports and deviation investigation reports
- Facilitates automation maintenance and manages Automation contracts and vendors
- Participates in automation user groups, such as VTN, MES, Pl and share relevant information with automation teams
Leading Self or Others or Department
- Demonstrates leadership behaviours in alignment with the Merck leadership standards
- Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements
- Efficient and structured in problem solving and trouble shooting.
- Demonstrates ability to work independently and able to define the scope and boundary when given or even when not clear.
- Work with different teams to meet common goals, provide end to end solutions and no functional boundaries
- Learn fast and resourceful enough to know how to network with different resources to develop a solution
- Effectively analyze, frame questions and present information in a clear and unambiguous manner to peers, supervisors, and management for decision making.
- Demonstrated project management skills to execute small projects or change control to work in cross functional team to complete project successfully.
- Bachelors in Electrical, Electronics, Chemical or Computer Engineering
- 10 to 15 years of technical experience in pharmaceutical manufacturing industry
Job: Manufacturing Automation Job Title:Sr. Spclst, Manufacturing Automation
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Engineer, Electrical, Law, Pharmaceutical, Testing, Engineering, Legal, Science, Technology