Validation Engineer (Onsite - Columbia, MO)

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.

About the role

As a Validation Engineer, you will ensure that manufacturing processes for both medical devices and drug products meet strict regulatory standards and consistently produce high-quality products. You will validate new and existing processes and equipment, develop and execute validation/qualification protocols, and ensure ongoing compliance with FDA, ISO, ISPE, and other relevant regulatory guidelines.

Responsibilities

• 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.
• 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).
• 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.
• 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.
• Support ongoing monitoring of validated processes and periodic re-validation activities as required.
• Investigate and resolve issues that arise during production related to process validation.
• Coordinate project meetings, steering committees, workshops, and the production of related documentation.
• 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.

Requirements

• Bachelor’s degree or higher in a science or engineering discipline (completed and verified prior to start).
• Five (5) years of validation and/or engineering experience in the pharmaceutical, medical devices, and/or biotech industry.
• 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.

Skills

• 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.

Schedule

Work location: Onsite in Columbia, MO.

Travel: May include up to 10% domestic/international.

Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).

Pay

The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay, if eligible. The specific compensation offered may vary based on factors including, but not limited to, relevant knowledge, training, skills, work location, and experience.

Benefits

This position may be eligible for a range of benefits, including:

• Medical, Dental, and Vision insurance.
• Health Savings Accounts.
• Health Care and Dependent Care Flexible Spending Accounts.
• Disability Benefits.
• Life Insurance.
• Voluntary Benefits.
• Paid Absences.
• Retirement Benefits.

Additional information is available at: Solventum Total Rewards.