MES Engineer 2

Responsible for overseeing and executing MES validation activities related to the gLIMS implementation. This role ensures that all validation deliverables are completed on time and in full compliance with global guidelines and standards. Responsible for supporting activities such as requirements gathering, testing, integration and implementation of Manufacturing Execution Systems (MES) in conjunction with gLIMS. Position is expected to operate with some supervision and some autonomy., * Lead gLIMS-MES interface validation activities and ensure timely completion and approval of all validation-related deliverables and documents.

• Collaborate closely with the Site Change Manager and Automation SME to ensure all impacted local MES/LIMS SOPs and processes are updated or replaced and compliant with global and local quality standards and gLIMS process SOPs.
• Work closely with gLIMS/MES leads, system users and process owners to develop and revise MES recipes in a timely manner to support gLIMS interfacing.
• Configure production recipes using a library of objects if required.
• Execute test scripts (design , execution, simulation, etc.) with support and guidance from supervisor / Validation SME
• Ensure the validation process meets regulatory and quality standards.
• Perform other duties as assigned.

• Bachelor of Science in Applicable STEM field or Computer Science with relevant experience.
• Advanced - 5-10 years in Automation, QC, Validation Pharma/Biotech
• Proficiency in using MES / LIMS or similar systems and familiarity with quality standards and regulatory requirements
• Extensive experience in validation processes.
• Strong understanding of The Organization’s CSV validation guidelines, templates, and SOPs.
• Excellent project management skills to lead and coordinate MES validation activities.
• Effective communication and collaboration skills to work with various stakeholders.
• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Strong written and verbal communication skills
• Ability to work in MS Project, Word, Excel, PowerPoint

Environmental Demands: The normal working environment is: Office Setting Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.