Drive digital excellence in pharma-be the Automation SME powering compliance, innovation, and efficiency across Belgian manufacturing sites.
Proclinical is seeking an Automation Subject Matter Expert (SME) to provide automation expertise across our client's manufacturing facilities. In this role, you will ensure quality compliance and efficiency in automation deliverables throughout the project lifecycle. This position involves collaboration with cross-functional teams, including Production, Quality Assurance, Qualification, and IT, to ensure compliance with cybersecurity and virtualization regulations.
Responsibilities:
1. Develop and maintain automation documentation and software.
2. Participate in workshops and align project disciplines.
3. Collaborate with automation integrators and vendors to ensure project success.
4. Verify deliverables and proactively address potential cost increases.
5. Ensure compliance with GMP (Good Manufacturing Practices) and HSE (Health, Safety, and Environment) standards.
6. Organize operator training sessions and facilitate handover to operations teams.
Key Skills and Requirements:
7. Strong expertise in automation systems, including PCS7 and AVEVA SP.
8. Experience with implementing new production processes, equipment, and optimization projects.
9. Knowledge of upgrading and maintaining automation infrastructures.
10. Familiarity with integrating new buildings, site utilities, and research facilities into existing systems.
11. Ability to work collaboratively with cross-functional teams to achieve project goals.
12. Strong understanding of GMP and HSE compliance requirements.