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
