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Systems Development Manager
2 weeks ago
The Manufacturing Systems Leader is responsible for the overall management and maintenance of the manufacturing execution system (MES) at our facility. This role requires strong technical expertise and experience with MES systems, as well as excellent communication and collaboration skills.
Key Responsibilities:- Troubleshoot and resolve issues with MES & ERP problems in recipe execution and authoring.
- Collaborate with Quality Assurance to provide approved change control documentation for all MES system changes.
- Design, create, write, and execute high-quality test and validation protocols, risk assessments, and system documentation.
- Make required changes to MES & ERP Recipes, worksheets, equipment, and material spec's, including phase transition logic, to a high-quality standard.
- Ensure cleaning, equipment, and product procedures are aligned to MES processes and vice versa.
- Provide training for site personnel on their related MES roles and arrange system access.
- Participate in MES knowledge exchanges, governance meetings, and manage issues, work-arounds, and fixes identified.
- Work closely with IT regarding upgrades, patching, hardware support, security, and system access.
- Liaise with Global MES on required system improvements.
- Provide support to other MES system users to ensure business continuity.
- Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
- Maintain and replace MES hardware, printers, scales, scanners, and bar-code labelers, reviewing for upgrades periodically.
- Keep other MES Team Members up to date on MES changes and document all activities in line with cGMP requirements.
- Cross train within the team and train new team members.
- Participate in continuous improvement programs to implement improvements in quality, safety, environmental, and production systems.
- Adhere to and support all health and safety standards, procedures, and policies.
- Hands-on experience with ASPEN product 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 and recipe is mandatory.
- Knowledge of 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.
