MANUFACTURING PROCESS ENGINEER
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.
- 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.