Quality Engineer - Validation

Job Title: Quality Engineer II

Department/Division: Quality Assurance

Reports to: Quality Engineering Supervisor

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 an experienced Quality Engineer with a strong validation background to provide ongoing support for process development and design transfer from R&D to Commercial Production. You will ensure our transdermal and oral thin film products (including mixing, coating, slitting, converting, and packaging) meet regulatory requirements and customer specifications. This exciting opportunity spans the entire product lifecycle, from feasibility and development through optimization, registration, and validation.

This is a full-time role located in West St. Paul, MN.

• After the initial training period, role can be remote up to 2 days/week.

***Relocation assistance is not provided for this role.***

What You Will Do:

• Corporate Policy & Support: Maintain the highest ethical standards, ensure accurate documentation (MBRs, RAs, protocols, reports, SOPs), conduct risk management activities (FMEA), and support deviation and change control processes.
• Commercial Product Support: Author and maintain batch records, specifications, and production forms; create protocols, reports, and deviations; perform risk management activities (Annual Product Reviews, FMEAs, Change Controls, Deviations); and author Continued Process Verification reports and Risk Assessments.
• R&D Program Support: Apply QbD principles to generate robust processes, provide DOE feedback, analyze data, review feasibility and clinical documentation, and collaborate on risk management activities.
• Internal Projects: Support qualification efforts, provide guidance on deviations and change controls, maintain and improve procedural documentation, and research and recommend quality and equipment controls.

Your Background:

• Bachelor's degree in science, engineering, or life sciences.
• 5+ years of quality experience in a regulated pharmaceutical, biopharmaceutical, or medical device environment.
• Demonstrated knowledge of manufacturing equipment and processes (level commensurate with experience).
• Working knowledge of cGMP, ISO, ISPE, and ANSI/ASQ standards and guidelines.
• Experience with regulatory agencies, filing pathways, and product types (level commensurate with experience).
• Proven ability to lead qualification efforts on equipment, systems, and software.
• Strong understanding of GAMP5.
• Experience with Continued Process Verification and Process Validation reporting.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills.

Preferred Qualifications:

• Led Qualification efforts on equipment, systems, and software.
• Knowledge of GAMP5.
• Experience with Continued Process Verification reports and Process Validation reports.

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.