The Project / Process Engineer will play a pivotal role across commissioning, start-up, and operations of single-use skid systems and biologics processes, acting as the technical bridge between manufacturing, MSAT, suppliers, and automation teams.Key Responsibilities
- Commissioning & Validation
- Assist with FATs, commissioning, IQ/OQ, and operational qualification (OQ) of single-use skids and biologics process assets.
- Start-up & Supplier Coordination
- Support plant start-up efforts and act as liaison with suppliers throughout project lifecycle.
- Cross-functional Collaboration
- Work closely with automation, QA/Validation, MSAT, and HSE teams—especially in safety assessments, HAZOP reviews, and process risk frameworks.
- Manufacturing Support & Troubleshooting
- Provide hands-on support for commissioning and early manufacturing, supporting troubleshooting, deviations, CAPA, and technical change controls
Preferred Background & Skills
- Bachelor’s or Master’s degree in Biological, Chemical, or Process Engineering, or related disciplines
- Experience in biologics manufacturing, particularly upstream processing) is highly desirable.
- Hands-on familiarity with single-use systems/skids is a strong advantage.
- Prior exposure to manufacturing or MSAT roles, including technology transfer, validation, and commissioning.
- Demonstrated experience in start-up, FAT/OQ/IQ, and supplier management.
- Solid understanding of automation interfaces, and collaboration with automation teams.
- Knowledge of safety protocols, including HAZOP, process safety, and GMP/regulatory expectations.
- Strong analytical, technical writing, and stakeholder communication abilities.
- Able to navigate fast-paced, cross-functional environments effectively.