Senior Process Engineer

Responsibilities

• Provide process engineering support for the implementation and sustainment of the MES (PAS-X).
• Author, review, and maintain GMP-compliant Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to MES usage, electronic batch records, and process execution.
• Support electronic batch record (eBR) execution, including troubleshooting and continuous improvement activities.
• Ensure alignment of MES functionality with process design, batch execution, and quality systems and compliance requirements.
• Collaborate with cross-functional teams to ensure successful MES integration with manufacturing processes and business systems.
• Contribute to MES-related design review, testing activities and go-live readiness.
• Providing support for the manufacturing of clinical supply drug substance, including resupply activities.
• Contribute to the evaluation, implementation, and qualificati...