Description:
Our client is looking for an experienced Process Engineer to join their team to support the design, qualification, and management of single-use technologies at their biologics plant. The Process Engineer will interact with vendors, review technical drawings, train operators, troubleshoot issues, and drive process improvements. You'll work closely with the Manufacturing, Engineering, Quality, and Operations teams.
Responsibilities:
- Serve as Process Engineer for Fill Finish Manufacturing, providing design input for equipment commissioning and qualification.
- Oversee the design, onboarding, and qualification of single-use systems, representing the site in cross-site standardisation efforts and collaborating with suppliers.
- Develop process flow diagrams for new product introductions and align with NPI Lead on product transfers and process improvements.
- Act as the technical expert for investigations, process improvements, and efficiency monitoring.
- Author gap assessments, facility fit studies, and risk assessments for new product introductions.
- Prepare scientific reports, technical documentation, and presentations to communicate project progress to stakeholders.
- Ensure compliance with safety, regulatory, and other compliance standards.
- Perform additional duties as needed.
Requirements:
- Third-level degree in Chemical Engineering, Bioprocess Engineering.
- 3-5 years experience in biopharmaceutical industry.
- Single-Use Technology Expertise: Experience in the design and qualification of single-use technologies in drug product/fill finish or drug substance environments.
- Vendor Management: Proven experience in managing relationships and collaborating with vendors.
- Operations & Design Experience: Background in the operations or design of single-use technology, including onboarding these systems into a facility.
- Cross-functional collaboration: Ability to work closely with Operations/Manufacturing teams on training and continuous improvement initiatives related to single-use technology.