- “Employees feel good about the ways they contribute to the community.”
- “Employees are proud to tell others they work here.”
- “you join the company, you are made to feel welcome
- “Management is honest and ethical in its business practices.”
- “People celebrate special events around here.”
This role provides leadership, support, and guidance to the MES support team to ensure that the business’ needs are met with daily support and maintenance.
- Coordinate the needs of functional groups and establish the priorities for MES requirements, system design and implementation and assign the appropriate project to the group.
- Conduct requirement and design session with users as needed for continuous process improvement
- Review company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact
- Develop strong business relationships with Clinical and Commercial groups to attain a solid understanding of their goals and objectives for better support with MES capabilities.
- Develop strong business relationships with Quality Assurance and Material Management for an understanding of their goals and objectives for alignment with MES capabilities
- Develop a strong business relationship with Information Technology to cultivate a solid understanding of roles and responsibilities with MES implementation and maintenance
- Align MES Support team’s business practices with Clinical and Commercial objectives to pro-actively anticipate future needs and create solutions to address them
- Assume responsibility for maintenance including all future upgrades, enhancements, and validations as needed and approved by senior management. Work with the system vendor to guarantee MES is up to date and can easily meet current and future business needs.
- Actively drive process improvement initiatives as appropriate.
- Provide system performance and usage metrics as required.
- Collaborate with appropriate Training groups to develop and schedule training sessions that best serve the business needs
- Provide MES team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals.
- Review and approve MES Change Controls
- Ensure GxP compliance
- Respond to audit inquiries
Education and Experience:
- BA/BS in engineering, biological or physical science, computer science, or information technology required.
- A minimum of 6 years of relevant experience including 2 years of experience working with MES or manufacturing systems within a life science manufacturing environment
- MES system configuration experience
- Experience in programming automation systems(DCS) and SQL preferred
- Familiarity with technologies used throughoutMES Process(i.e. Interfaces, Level 2, Integration, and Infrastructure), MES recipe configuration, MES workflow, SQL, Oracle, and relational database concepts
- Knowledge of Werum PAS|X
- Knowledge of integration of MES systems with ERP and Shop Floor systems
Telephone: 061 09 519