Davis Companies has partnered with a leading manufacturing company in the Twin Cities to identify an R&D Engineer to join their growing team!
Provide ongoing scale up, process development, and scientific support to the portfolio of products, client projects and upcoming projects across various industries. Product types will include supplements, pharmaceutical, environmental, medical device, and nutraceutical.
Principal Responsibilities of the R&D Engineer:
- Lead Design Reviews and contribute to activities in the development of commercial slitting, converting, packaging, cartoning and serialization processes for transdermal, dissolvable films and other drug products.
- Establish optimum process conditions for product quality, throughput and yield.
- Support Manufacturing Engineers with equipment specifications
- Support Validation group with IQ, OQ and PQ
- Lead FMEA and Risk Assessments with support of Validation and Quality
- Support operations with qualification / PM, commercial manufacturing activities
- Interface and provide technical leadership to project teams, vendors and clients in all activities from development to validation scale production.
- Support the hand-off of Developed Processes with robust control processes to Validation and Manufacturing
- Design/re-design tooling, part and packaging equipment for use in various projects
- Minimum of BS degree in science or engineering, advanced degrees preferred.
- Prefer 5 years hands-on experience in manufacturing process development and scale-up within the pharmaceutical industry with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive processes for medical or other applications.
- Proven track record of planning and executing process development/scale-up projects, and an ability to meet aggressive timelines.
- Knowledge and experience with cGMP for pharmaceuticals and QbD principles preferred.
- Knowledgeable and experienced with cGMP, cGLP, USP and the regulatory requirements for pharmaceuticals preferred.
- Demonstrated experience drafting R&D Manufacturing Records, SOPs, master plans and additional protocols
- Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.