Lead Technical Consultant (MES) - Part-Time

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.

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 groups