Lead Technical Consultant (MES)
at TECHNOPALS CONSULTANTS PTE LTD
Singapore, Southeast, Singapore -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 12 Jul, 2024 | USD 8000 Monthly | 13 Apr, 2024 | N/A | Mes,Packaging,Isa,Communication Skills,Business Process,Unit Operations | No | No |
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Description:
REQUIREMENTS
- Knowledge and experience in manufacturing Automation Systems, MES & Historian, Lab Systems and IT-OT will be preference.
- Werum PAS-X/ Aspen/ Syncade/ Siemens MES (Camstar / Opcenter / Simatic IT) product hands-on experience for full system configurations including interface with SAP and automation systems
- In-depth of knowledge of Pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
- Master Batch Record creation in Werum PAS-X
- Knowledge on Industry Standards S88 and ISA S95
- Experience working on projects in the pharmaceutical and/or biotechnology industries knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector
Excellent communication skills and collaborative with team members and external group
Responsibilities:
- Oversee the development of solutions and provide technical expertise on the development of platform features.
- Troubleshoot and provide solutions for MES & ERP problems in recipe execution and recipe authoring.
- Liaise with QA to provide approved change control documentation for all MES system changes.
- Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
- Design, create, write and/or make all required changes to MES & ERP Recipes, worksheets, equipment and material spec’s including phase transition logic to a high-quality standard.
- Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
- Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
- Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-around and fixes identified.
- Work closely with IT regarding upgrades, patching, hardware support, security and system access and provide technical expertise in implementing upgrades and patching.
- Liaise with Global MES on required system improvements.
- Provide support to other MES system users as required to ensure business continuity.
- Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
- Ensure maintenance/replacement of MES hardware, printers, scales, scanners and bar-code labelers. Review for upgrades periodically.
- Keep other MES Team Members up to date on MES changes Documentation of all activities in line with cGMP requirements.
- Cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
- Adheres to and supports all health and safety standards, procedures and policies.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Information Technology/IT
IT Software - Other
Help Desk, Software Engineering
Graduate
Proficient
1
Singapore, Singapore