R&D Process Engineer
Our client has an opportunity for a R&D Process Engineer. In this role you will provide ongoing scale-up, process development, and scientific support to the portfolio of the company products, client projects and upcoming projects across various industries.
- Lead and contribute to activities in the development of commercial converting, packaging and serialization processes for transdermal, dissolvable films and other drug products
- Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability, qualification and validation
- Establish optimum process conditions for product quality, throughput and yield
- Write specifications, protocols, SOPs, process development reports, etc
- Ensure regulatory compliance throughout all development activities
- Maintain accurate and complete records of development activities
- Support operations with equipment specification, qualification/PM, commercial manufacturing activities, etc
- Interface and provide leadership to project teams, vendors and clients in all activities from development to commercial scale production
- Provide technical and/or scientific guidance to operations and internal teams when appropriate
Our client services include formulation, optimization, blending, coating, converting, primary packaging, secondary cartoning, and kitting to commercially manufacture transdermal and oral thin film drugs.
Benefits available to team members:
- Medical / Dental Insurance
- Paid Holiday/ Vacation / PTO
- 401K w/ company match
- Life and Short/Long Term Disability
- Flex Spending Account
- Min of BS degree in Science or Engineering (mechanical/packaging) or related field, web-handling experience - Preferred!
- 3-5 years of hands-on experience in manufacturing process development and scale-up within the pharmaceutical/medical device industry
- Previous experience with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive processes for medical or other applications – Preferred!
- Knowledge and Experience w/ cGMP and the regulatory requirements for pharmaceuticals/medical devices - Preferred!
- Proven track record of planning and executing process development/scale-up projects, and an ability to meet aggressive timelines
- Motivated and Collaborative Team Player in a cross-functional team atmosphere
- Demonstrated problem-solving and analytical skills
- Strong technical writing and oral communication skills