Validation Engineer; Onsite - Columbia, MO

Job Description

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges.

While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy:  applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

As a Validation Engineer
, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by ensuring that manufacturing processes for both medical devices and drug products meet strict regulatory standards and consistently produce high-quality products. You will be involved in validating new and existing processes and equipment, developing and executing validation/qualification protocols, and ensuring ongoing compliance with FDA, ISO, ISPE and other relevant regulatory guidelines.

• Training & Mentorship
  Provide guidance and training to manufacturing and quality teams on validation processes, regulations, and best practices.
  Provide validation support for projects outside of the Columbia, MO manufacturing location.(as needed by the Corporation)
• Technical Knowledge of Process, Product, and Software Validations
  Develop, plan, support and execute process and test method validation activities for medical device and drug manufacturing processes, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Process Characterization (PC), Performance Qualification (PQ) and Product Performance Qualification (PPQ) (when applicable).
• Documentation and Compliance
  Create and maintain comprehensive validation documentation, including validation protocols and reports. Ensure compliance and identify gaps with Good Manufacturing Practices (GMP), FDA regulations, ISO standards, and other applicable regulatory requirements.
• Cross-functional Collaboration
  Collaborate with cross-functional teams, including Laboratory (R&D), Manufacturing, Quality Assurance, IT, and Regulatory Affairs, to support new product introductions, process changes, and continuous improvement projects. Communicate effectively with cross functional teams.
• Continuous Monitoring and Support
  Support ongoing monitoring of validated processes and support periodic re-validation activities as required. Investigate and resolve any issues that arise during production related to process validation. Coordinate project meetings, steering committees, workshops and the production of related documentation.
• Audits and Inspections
  Support internal and external audits and regulatory inspections by preparing and reviewing validation documentation. Participate in the response to audit findings related to process…