DAVIS Companies has partnered with a leading Manufacturing company in the Twin Cities to identify a Manufacturing Process Engineer to join their team! LOCAL candidates only please. 

Responsibilities of the Manufacturing Process Engineer:

• Lead Design Reviews and contribute to activities in the improvement of commercial mix, coat, slitting, converting, packaging, cartoning and serialization processes for transdermal, dissolvable films and other drug products.
• Assist and troubleshoot process / equipment issues that occur during commercial operations and product changeovers.  Including utilization and adjustments of Vision System programs and tools.
• Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability and qualification tied to changes on commercialized processes.
• Through CI activities enhance process conditions that increase quality, yield or reduce set-up and tear-down activities.
• Write specifications, R&D Mfg. instructions, protocols, SOPs, process development reports, etc.
• Support and follow all regulatory compliance aspects, including following the necessary change control processes.
• Lead, research and write equipment specifications with support from R&D
• Lead  / support CI activities that increase efficiencies on commercial processes
• Support Quality in NCM and CAPA investigations
• Support operations with qualification / PM, commercial manufacturing activities, etc.
• Provide technical and/or scientific guidance to operations and internal teams when appropriate.
• Receive the hand-off of Developed Processes with robust control processes from Validation and R&D
• Design/re-design tooling, part and packaging equipment for use in various projects

• Minimum of BS degree in science, engineering or related field, advanced degrees preferred.
• Minimum 10 years of direct industry experience  
• Bachelor’s degree in an Engineering or Science related field + 3 years of experience 
• Minimum 5 years hands-on experience in manufacturing process improvement / sustainability 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.
• Ability to review large amounts of data/information, identify trends, draw conclusions and support a position with text and data.
• Proven track record of planning and executing process re-development/ CI projects, and an ability to meet aggressive timelines.
• Highly motivated individual who can work both independently and as part of a cross-functional team.???????
• 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.

Preferred Qualifications:

• Knowledgeable and experienced with cGMP,  USP and the regulatory requirements for pharmaceuticals preferred.
• Experience in rotary die cutting and pharmaceutical primary and secondary packaging
• Demonstrated experience drafting 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.