Job Description
Senior Process Engineer (M/F/D)
Tasks:
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 qualification of new or modified equipment and ...
Tasks:
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 qualification of new or modified equipment and ...
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