An experienced Automation engineer/Senior Automation engineer to be responsible for the process automation design, operation and implementation and to lead technical project execution activities on all design phases as well as installation, start up, implementation.

· To identify customer needs and make excellent business proposal.

· SME in Facility Operational Technology, Machine Automation, Digitalization and Manufacturing Systems.

· Support technical availability, Operation, optimization, maintenance and life cycle management of buildings, systems, production and infrastructure equipment assigned to the automation department and support Site Automation & Digitalization projects.

· To lead and execute exciting projects and will provide support and offer guidance for internal activities such as: mock projects, toolbox development and mentoring of less experienced teammates.

· Creation of control IT Communication concepts.

· Creation and review of system life cycle documents (validation plan, requirement specifications, hardware and software specifications, risk analyses, FAT/SAT and IQ/OQ test plans, SOPs).

· Contact person for questions regarding IT-supported automation, digitalization of processes and future Industry 4.0 applications.

· Planning, execution and documentation of customer audits.

· Conception, planning and implementation of cyber security solutions in production-related environments (e.g. MES, PLC, DCS, SCADA).

Requirements

· Minimum bachelor’s degree in electrical engineering (focus on automation technology or control engineering), process engineering, pharmaceutical engineering, or comparable field of study.

· Familiar with relevant pharma EU, ICH, WHO, PDA, TGA&ISPE design guidelines and the orange guide.

· Minimum 10 to 15 years of relevant Experience in Automation and control systems, Projects and Operation.

· Expected job experience in Pharmaceutical, Bio Pharmaceutical, Medical device, Food industries.

· Knowledge of automation systems (SCADA, PLC, MES) such as: Siemens, Rockwell, Emerson, Werum or other automation software vendors.

Experience in IT security management as well as project management is desirable.

· Knowledge of international or local standard/code (e.g. GMP, ISPE baseline Guide, ASME BPE, and so forth). Good Experience in Bid Proposal.

· Knowledge of Production and Validation system sequence. Experience working in FDA regulated environment is preferred. Familiar in CGMP, GMP, CGDP Manufacturing Process.

• Design experience in manufacturing equipment, facilities, and processes for a pharmaceutical company. Create and maintain design standards for global Bioengineering network.


• Good technical understanding in general with knowledge in engineering, process and /or utilities for pharma and biopharma plants (P&ID, IQ/OQ URS, FATs, SATs…)


• Experience in Automation systems (PCS – DeltaV/Siemens or equivalent, PLC’s – Siemens, Rockwell or equivalent, Data analytical tool- OSI PI, IP 21 or equivalent)


• Experience working with Infrastructure (VMWare, Hyper-V) and networks (Control networking protocols which includes but not limited to Ethernet/IP, Profibus, ProfNet, fieldbus, Device Net and Bus related technologies). Cloud knowledge will be added advantage.


• Knowledge about MES, Working experience in start-ups, commissioning & qualification (CSV) of Automation and process control systems.


• Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards


• Knowledge in Singapore local statutory regulatory requirements, code of practices related to process industry projects.


• Good knowledge in project procurement to handle vendor & subcontract management, RFQ, tender review, technical and commercial bid analysis report for the projects proposed.


• Hands on experience with Network Infrastructure, Windows Active Directory and Domain Controller, Cybersecurity Architecture, Cluster Administration tools, Backup and Restoration tools will be an advantage for this role.