Seeking a Manufacturing Engineer! Job Description Provide ongoing commercial process support, improvement, continuous improvement initiatives, equipment selection/support, and scientific support to the portfolio of TM products that are in commercial and transitioning into commercial across various industries. Support the portfolio of TM products and projects in accordance with cGMP, FDA, and DEA regulations and standards. Responsibilities + Lead design reviews and contribute to activities in the improvement of commercial liquid mix, solution coating for transdermal, dissolvable films, and other drug products. + Select pumping, mixing, and coating equipment to achieve desired manufacturing processes. + Assist and troubleshoot process/equipment issues that occur during commercial operations and product changeovers. + Plan and execute process studies for feasibility, development/characterization (DOEs), capability, and qualification tied to changes on commercialized processes based on QbD principles. + Enhance process conditions through continuous improvement activities that increase quality, yield, or reduce set-up and tear-down activities. + Update specifications, R&D manufacturing instructions, protocols, SOPs, process development reports, etc. used in enhancing existing commercial processes. + Support and follow all regulatory compliance aspects, including necessary change control processes. + Lead, research, and write equipment specifications with support from R&D. + Lead/support continuous improvement activities that increase efficiencies on commercial processes. + Support Quality in NCM and CAPA investigations. + Maintain accurate and complete records of development activities on commercialized processes. + Support operations with qualification/PM, commercial manufacturing activities, etc. + Interface and provide leadership to project teams, vendors, and clients in all activities from re-development to ongoing commercial production. + 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. + Familiarity with flammable solvents and their safety codes and machine features. + Ability to redesign major complex processes and products within the company's focus. Essential Skills + 4+ years of experience in manufacturing process engineering. + 1+ years of experience in coating. + Process support and improvement. + Manufacturing process and engineering. + Pharma or medical device industry knowledge. + Continuous improvement and lean manufacturing. + Six Sigma. + GMP experience. + FDA compliance. Additional Skills & Qualifications + Slot die coating, comahead, and roll to roll coating experience + Experience with VIVA for QMS and Minitab for CAD. + CAD certifications. + CGMP experience. + Technical writing. + Chemical engineering knowledge. Pay and Benefits The pay range for this position is $90000.00 - $115000.00/yr. Medical insurance, HSA set up, Dental Insurance, Group Life Insurance, 410K plan, Vacation time, PTO, Paid time off for volunteer work, short and long-term disability. Workplace Type This is a fully onsite position in Saint Paul,MN. Application Deadline This position is anticipated to close on Feb 10, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.