Quality Engineer

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.

Lohmann Therapy Systems North America is searching for a talented Quality Engineer to join our Quality Assurance Team.
This is a full time, hybrid role located in West St. Paul, MN
Hybrid = onsite minimum of 3 days per week with opportunity to work remote up to 2 times a week as project allow.

Job Summary:

Provide quality engineering support for pharmaceutical and medical device product development and commercialization, focusing on transdermal and oral thin films. Ensure product quality and compliance through process development, improvement, and documentation.

What You Will Do:

  • Design, execute, and analyze quality engineering studies (DOE, IQ/OQ/PQ/PV, FMEA, process capability).
  • Develop and maintain product documentation (MBRs, specifications, SOPs, validation/qualification protocols/reports, risk assessments).
  • Support process improvement initiatives through change control and root cause analysis.
  • Collaborate with cross-functional teams to ensure product quality and compliance.
  • Participate in audits and regulatory interactions.

Your Background:

  • Bachelor’s degree in engineering or technical field.
  • 3-5 years’ experience in pharmaceutical/medical device industry.
  • Knowledge of pharmaceutical mixing, coating, and converting processes.
  • Strong understanding of quality systems, regulations (FDA, ISO), and statistical analysis.
  • Excellent written and verbal communication skills.
  • Ability to work independently and collaboratively in a fast-paced environment.

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.

Department/Division: Quality Assurance
Reporting to: Supervisor, Quality Engineering
Grade: 12