Job Description
We are seeking a Process Engineer (MSAT / Manufacturing) to support a biopharmaceutical manufacturing program. This role sits within the Process / MSAT team, focusing on process qualification, validation, and process performance support in a GMP-regulated environment. The position requires strong process understanding, qualification ownership, and cross-functional collaboration with Manufacturing, QA, and Automation teams. Key Responsibilities
Own and drive Process Qualification (PQ) execution, including protocol support and on-floor execution Support process validation lifecycle activities (PPQ / CPV) in alignment with GMP requirements Perform process troubleshooting, deviation support, and root cause analysis Collaborate with MSAT, QA, and Manufacturing teams to ensure process consistency and compliance Analyze process data and trends to support continuous improvement initiatives Support change control, validation documentation, and qualification deliverables Work closely with Aut...
Own and drive Process Qualification (PQ) execution, including protocol support and on-floor execution Support process validation lifecycle activities (PPQ / CPV) in alignment with GMP requirements Perform process troubleshooting, deviation support, and root cause analysis Collaborate with MSAT, QA, and Manufacturing teams to ensure process consistency and compliance Analyze process data and trends to support continuous improvement initiatives Support change control, validation documentation, and qualification deliverables Work closely with Aut...
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