Process Engineer – Manufacturing / MSAT (Biopharmaceutical), Singapore

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 Automation (e.g., DeltaV) for process understanding and operational alignment Ensure all activities comply with cGMP, regulatory, and site quality standards Requirements Bachelor's degree in Chemical Engineering, Biotechnology, or related field 5+ years of experience in biopharmaceutical manufacturing Hands-on experience in process qualification (PQ) execution - must have ownership experience Strong exposure to process validation lifecycle (PPQ, CPV) Experience in deviation investigation, CAPA, and process troubleshooting Good understanding of GMP, validation practices, and regulatory expectations Familiarity with DeltaV or similar automation systems (process understanding level) Experience working in MSAT / Process Engineering / Manufacturing support roles