As Sr. Process Engineer you will 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. Scale up activities will be tailored towards transdermal, oral thin films, medical device and topical products.
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.
Minimum of BS degree in science or engineering (mechanical/packaging) or related field, web-handling experience preferred.
Minimum 10 years of direct industry experience (Senior level)
3 - 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.
Ideal candidate will bring a mechanical engineering degree within pharmaceuticals, or medical device with rotary die cutting experience or exposure to. This is a very unique opportunity with a company that continues to grow. If you are a Project Engineer or Mechanical Engineer working in a pharma or medical device manufacturing company, supporting production, formulation, packaging, qualifying R&D equipment, etc. this would be a great opportunity for you to consider.
Relocation assistance offered to out of state candidates. Start the New Year off with a new career with an outstanding employee first company. Please submit your resume to firstname.lastname@example.org