Customer driven, growing company with over 70 years in business in need of an experienced process engineer with some experience assisting in protocol writing, working with validations in regulated environment.
As Sr. R&D Process Engineer you will report to the VP of Engineering, providing 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 nutraceuticals. Scale up activities will be tailored towards transdermal, oral thin films, medical device and topical products.
Please send resumes to email@example.com
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 (DOE's), capability, qualification and validation.
Establish optimum process conditions for product quality, throughput and yield.
Write specifications, protocols, SOP's, 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.
Must have BS degree in engineering (mechanical) or related field, web-handling experience a plus
Minimum of 5 years hands-on experience in manufacturing process development and scale-up within the pharmaceutical industry, preferably 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.
Highly motivated individual who can work both independently and as part of a cross-functional team.
Demonstrated problem-solving and analytical skills
Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing.
Knowledge and experience with cGMP for pharmaceuticals and QbD principles preferred.
Knowledgeable and experienced with cGMP and the regulatory requirements for pharmaceuticals preferred.
Demonstrated experience drafting URS, 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.
Outstanding company to work for, mid-sized facility where you can make a difference, flexible work schedule with excellent benefits, competitive base salary and fun place to work.