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.
Education and Experience:
- Bachelor’s degree in engineering or technical science with 1-3 years of industry related experience
- Demonstrated ability to work independently and collaboratively in cross-functional teams
- Strong interpersonal skills, communication skills and documentation skills are required
- Ability to generate results and perform work with minimal supervision.
- Comfortable in a fast-paced, diverse environment with ability to adjust workload based upon changing priorities
- Experience in prior automation implementation at large scale
- Project Management experience of multiple simultaneous projects and teams
- Demonstrated ability to defend and justify capital expenses to achieve upper management approval
- Negotiating experience with external vendors
- Experience with liquid handling, fill/finish, robotics, labeling systems, packaging and process integration
- Experience working under GMP and medical device guidelines.
- Strong team player, self-motivated, and willing to learn new techniques and concepts.
- Knowledge in product transfer and manufacturing in compliance with ISO quality systems