Packaging Process Engineer
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.
Position Summary:
We seek a highly creative and driven Packaging Process Engineer to join our Process Engineering team. You will work within a highly dynamic group serving as a key resource to advise, select, design and implement suitable packaging solutions for a wide variety of sterile and non-sterile products. You will play a key role in guiding packaging strategy for new and existing products for our Cell & Gene Therapy, Immunoassay, Diagnostics, Protein and Antibody business units.
Key Responsibilities:
- Review product and business needs to determine appropriate primary, secondary and tertiary packaging for Bio-techne products. This includes sterile flexible bags, sterile and non-sterile vials and bottles, plates, cartridges, foil pouches, plastic and cardboard boxes containing mixed products and insulated and non-insulated shippers.
- Be that go-to person that identifies and implements the most appropriate packaging solution given the product type and customer requirements. This will include sterile and non-sterile packaging of Research Use Only (RUO), Good Manufacturing Practices (GMP), In Vitro Diagnostics (IVD) and other medical devices per appropriate CFR, ISO 9001 & 13485 requirements.
- Serve as lead for technical packaging issues to execute and coordinate testing and validation of packaging solutions
- Work with external vendors to identify solutions and coordinate any custom packaging designs as needed
- Work closely with the Marketing team, Automation team, Product Development, Operations, Quality, Regulatory and others to ensure the packaging solution identified meets customer and company needs.
- Work with the Automation and Operations teams to ensure compatibility with existing equipment & workflows; if appropriate, coordinate selection and implementation of future equipment as needed.
- Manage multiple projects simultaneously to keep projects on track and timeline for completion.
- Build and maintain effective collaborations with Manufacturing, Process Engineering, Development, Marketing, Quality Assurance and Regulatory groups.
Education and Experience:
- Bachelor’s degree in packaging, engineering, biomedical or related technical science with 0-5 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
Preferred Qualifications:
- Experience working under GMP and medical device guidelines.
- Familiarity with eco-friendly alternatives and trends in packaging design
- Experience in automation implementation
- Project Management experience of multiple simultaneous projects and teams
- 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