Manufacturing Engineer
3 weeks ago
Job Title: Manufacturing Engineer III or IV Department/Division: Engineering Reports to: Principle/Staff Engineer or Engineering Management About LTS: LTS Lohmann is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners' market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary Lohman Therapy Systems North America is seeking a highly motivated and results-oriented Manufacturing Engineer to support commercial and transitioning pharmaceutical products. This role will lead and contribute to process improvements, equipment selection, troubleshooting, and continuous improvement (CI) initiatives. The ideal candidate will work cross-functionally to ensure compliance with cGMP, FDA, and DEA standards while driving operational excellence. This is a full time role located in West St. Paul, MN.***Relocation assistance is not provided for this role.***What You Will Do: Lead design reviews and improve commercial processes including mixing, coating, slitting, converting, packaging, cartoning, and serialization. Troubleshoot equipment and process issues during commercial operations and product changeovers. Utilize Vision System tools and programs for process optimization. Plan and execute process studies (DOEs) based on QbD principles. Author and update specifications, SOPs, protocols, and development reports. Support regulatory compliance and change control processes. Lead and support CI initiatives to improve efficiency, yield, and quality. Interface with project teams, vendors, and clients from development through commercial production. Provide technical and scientific guidance to internal teams and operations. Design and re-design tooling, parts, and packaging equipment. Maintain accurate records of development and qualification activities. Support Quality investigations (NCM, CAPA) and preventive maintenance programs. Your Background: Bachelor's degree in mechanical engineering or related field. Minimum 3-4 years of direct industry experience in pharmaceutical or medical adhesive manufacturing. Strong analytical skills with the ability to interpret data and trends. Proven track record of executing CI projects and meeting aggressive timelines. Excellent organizational, communication, and technical writing skills. Knowledge of cGMP, QbD, and regulatory standards (FDA, DEA, USP). Preferred Qualifications Proficiency in CAD software; CAD certification. Experience in rotary die cutting and pharmaceutical packaging. Experience with transdermal and oral dissolvable thin film products preferred. Green Belt certification. Demonstrated ability to draft Manufacturing Records, SOPs, master plans, and protocols. Familiarity with statistical analysis tools. We Offer Competitive compensation and benefits package Opportunities for professional growth and development A collaborative and supportive work environment The chance to contribute to improving patient lives If this sounds like you, we want to hear from you LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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