Roles & Responsibilities
The last number of years has seen significant growth in the use of Manufacturing Execution Systems (MES) within the Life Science industry. With this trend set to continue, We are looking for dedicated, innovative and driven talent to join our expanding MES team.
We are are looking to hire a Senior/ Systems Programmer 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
- Werum PAS-X/Aspen/Syncade, Siemens MES (Camstar / Opcenter / Simatic IT) product hands-on experience for full application 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)
- Creation of business process flow diagram
- 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 groups
