Validation Engineer (Onsite - Columbia, MO)

USA SOLVENTUM US LLC; Columbia Township (MO); On-site; USD 106,000 - 146,000; Full time

Job summary

Solventum seeks a Validation Engineer to validate manufacturing processes for medical devices and drug products in Columbia, MO. You will develop and execute IQ/OQ/PQ/PPQ protocols, assemble validation documentation, and ensure GMP and FDA compliance while collaborating with R&D, Manufacturing, QA, IT, and Regulatory Affairs.

You will also lead or support audits, drive continuous improvement, and participate in change management across cross-functional teams in a regulated environment.

Qualifications

• Bachelor’s degree or higher in science or engineering completed prior to start.
• Five years of validation and/or engineering experience in the pharmaceutical, medical devices and/or biotech industry.
• Experience applying cGMP, FDA regs in a regulated environment.
• Experience working with cross-functional teams to support validation and manufacturing 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.

Responsibilities

• Develop, plan, support and execute process and test method validation activities for medical devices and drug products (IQ/OQ/PQ/PPQ).
• Create and maintain comprehensive validation documentation and ensure GMP/FDA/ISO compliance.
• Collaborate with cross-functional teams (R&D, Manufacturing, QA, IT, Regulatory Affairs) to support new product introductions and process changes.
• Support ongoing monitoring and re-validation activities as required; investigate issues in production related to process validation.
• Coordinate project meetings, steering committees, workshops and related documentation; participate in audits and inspections.

Skills

Validation experience

cGMP compliance

FDA regs knowledge

Cross-functional teamwork

Continuous improvement

Lean Six Sigma

Process validation

Software validation

Facilities & utilities validation

Change management

Education

Bachelor’s degree in science or engineering

Five years validation/engineering experience

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: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ 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.

Job Description: Validation Engineer (Solventum)

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.

The Impact You’ll Make in this Role

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.

Your Skills and Expertise

• 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
• 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
• 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.

Work location

Onsite in Columbia, MO

Travel: May include up to 10% domestic/international

Relocation Assistance

May be authorized

Employment Authorization

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

Supporting Your Well-being

Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Applicable to US Applicants Only: The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

Equal Opportunity Statement

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Company Culture and History

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.