MES Systems Manager, ASPEN - LSMG

COGNIZANT TECHNOLOGY SOLUTIONS ASIA PACIFIC PTE. LTD.; Singapore; On-site; SGD 75,000 - 100,000; Full time

Job summary

A leading technology solutions firm in Singapore seeks an experienced MES Systems Manager to join their MES team for a pharmaceutical client. Responsibilities include troubleshooting MES & ERP problems, designing test protocols, and ensuring compliance with cGMP requirements. The ideal candidate has ASPEN product experience and knowledge of pharmaceutical business processes. This position offers the opportunity to work in a dynamic environment focused on improving technology and processes.

Qualifications

• Hands-on experience with ASPEN product and full application configurations.
• In-depth knowledge of pharmaceutical business processes required.
• Experience with GAMP lifecycle and quality management processes.

Responsibilities

• Troubleshoot MES & ERP problems in recipe execution.
• Design and execute high-quality test and validation protocols.
• Provide support to other MES system users.

Skills

ASPEN product hands-on experience

In-depth knowledge of pharmaceutical business processes

Knowledge on Industry Standards S88 and ISA S95

Excellent communication skills

Job description

Overview

We are are looking to hire a MES Systems Manager to join our MES team working at our client site, a pharmaceutical MNC. The selected candidate will be required to provide consultation and engineering service to the execution phase of the project. He/she will also be involved in the generation and ownership of IQ/OQ/PQ documentation and the GoLive Support.

Responsibilities

• 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.

Requirements

• ASPEN product hands-on experience for full application configurations including interface with SAP and automation systems
• In-depth knowledge of Pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
• Creation of business process flow diagram & recipe is a MUST.
• 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 groups

About Cognizant

Cognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we\'re improving everyday life. See how at www.cognizant.com or @cognizant.