By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
We seek a highly creative and driven Automation Fill/Finish Process Engineer to join our Process Engineering team. You will work within a highly dynamic group serving as a resource for implementation, expansion and enhancement of automation solutions used in Manufacturing and Fill/Finish Operations. You will play a key role in expanding the use of Automation to increase manufacturing efficiency.
- Analyze, recommend and implement process improvements to manufacturing and Fill/Finish processes, with focus on automation techniques and equipment.
- Improve manufacturing efficiency by analyzing and planning automated alternatives to existing processes supporting products across the Bio-techne portfolio. This includes liquid handling in vials, bottles and bags, aseptic/sterile processes, labeling, vision systems, kit packing and packaging for Research Use Only (RUO), Good Manufacturing Practices (GMP), In Vitro Diagnostics (IVD) and other medical devices per appropriate CFR, ISO 9001 & 13485 requirements.
- Coordinate with internal staff and external vendors to design, refine and implement automation solutions.
- Coordinate with our Quality team to design and implement IQ/OQ/PQ and validation protocols.
- Execute and coordinate validations in compliance with appropriate regulatory requirements.
- Prepare business cases and justification for capital expenditures and obtain necessary internal approvals.
- Propose potential new manufacturing technologies, including, but not limited to, automation and new equipment.
- Manage multiple projects simultaneously to keep projects on track and timeline for completion.
- Build and maintain effective collaborations with Manufacturing, Process Engineering, Development, Quality Assurance and Quality Control groups.