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Validation Engineer (Onsite - Columbia, MO)
Summary
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.
Responsibilities
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 validation.
Experience Requirements
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher in a science or engineering discipline (completed and verified prior to start) AND five (5) years of validation and/or engineering experience in the pharmaceutical, medical devices and/or biotech industry
In addition to the above requirements, the following are also required:
- Experience applying cGMP, FDA 21 CFR Part 210/211, 21 CFR Part 820, 21 CFR Part 11, EudraLex Volume 4, and/or other applicable regulatory requirements within a regulated environment
Additional qualifications that could help you succeed even further in this role include:
- Experience working with cross-functional teams to support validation, engineering, quality, manufacturing, or operational activities.
- Experience leading or participating in continuous improvement projects.
- Lean Six Sigma certification.
- Experience performing process validation, software validation, commissioning, and/or qualification activities for manufacturing equipment.
- Experience supporting facilities and utilities systems within a regulated manufacturing environment.
- Experience leading change management initiatives associated with programs, projects, or operational improvement
Benefits
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