What are the responsibilities and job description for the MES Lead PharmaSuite position at Katalyst CRO?
Job Summary
- We are seeking an experienced Pharma Suite MES Lead to support and lead the Manufacturing Execution System (MES) operations for a global pharmaceutical manufacturing environment.
- The ideal candidate will have expertise in Rockwell Pharma Suite FTPS 11.0, pharmaceutical manufacturing processes, MES support, incident and change management, and stakeholder coordination to ensure the stable, compliant, and efficient operation of manufacturing systems across multiple sites.
- Lead the PharmaSuite MES support and enhancement team across multiple pharmaceutical manufacturing sites.
- Provide technical and functional support for the Rockwell PharmaSuite FTPS 11.0 Manufacturing Execution System (MES).
- Serve as the primary point of contact between business stakeholders, manufacturing operations, quality teams, and technical support teams.
- Ensure the stable, compliant, and efficient operation of the PharmaSuite platform.
- Manage and coordinate incident, problem, and change management activities for MES applications.
- Support manufacturing operations by troubleshooting MES-related issues and implementing system enhancements.
- Coordinate system upgrades, enhancements, and deployments while minimizing production impact.
- Collaborate with Quality, Manufacturing, Engineering, and IT teams to ensure MES solutions comply with pharmaceutical regulatory and quality standards.
- Monitor system performance and drive continuous improvement initiatives to enhance operational efficiency.
- Support global MES operations by ensuring timely resolution of production issues and maintaining system availability.
- Participate in project planning, implementation, and validation activities related to PharmaSuite MES.
- Maintain system documentation, standard operating procedures (SOPs), and support documentation.
- Bachelor's degree in Engineering, Information Technology, Computer Science, Pharmacy, Life Sciences, or a related field.
- 6-8 years of experience supporting Manufacturing Execution Systems (MES) within the pharmaceutical manufacturing industry.
- Strong hands-on experience with Rockwell PharmaSuite FTPS 11.0.
- Good understanding of pharmaceutical manufacturing operations and manufacturing execution processes.
- Experience leading MES support, enhancement, and maintenance activities across multiple manufacturing sites.
- Strong knowledge of incident management, problem management, and change management processes.
- Experience working with cross-functional teams, including Manufacturing, Quality, Engineering, IT, and Business stakeholders.
- Excellent stakeholder management, communication, and leadership skills.
- Experience supporting global manufacturing operations in a regulated pharmaceutical environment.
- Strong analytical, troubleshooting, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Knowledge of GMP, GxP, and pharmaceutical manufacturing compliance is preferred.
- Experience with Manufacturing Quality Execution Systems (MQES) and MES lifecycle management is an added advantage.