Process Validation Leader

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. 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:Process Validation Leader (Solventum)3M Health Care is now SolventumAt 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 RoleAs a Process Validation Leader, 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, developing and executing validation protocols, and ensuring ongoing compliance with FDA, ISO, and other relevant regulatory guidelines.         Process ValidationDevelop, plan, and execute process validation activities for medical device and drug manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Performance Qualification (PPQ) (when applicable).Documentation and ComplianceCreate and maintain comprehensive validation documentation, including validation protocols and reports. Ensure compliance with Good Manufacturing Practices (GMP), FDA regulations, ISO standards, and other applicable regulatory requirements.Cross-functional CollaborationCollaborate 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.Training & MentorshipProvide 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.Continuous Monitoring and SupportSupport 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.Audits and InspectionsSupport 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 ExpertiseTo 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 AND ten (10) years of validation experienceORHigh school diploma/GED AND fourteen (14) years of validation experienceAdditional qualifications that could help you succeed even further in this role include:Master's degree or higher in a science or engineering disciplineProven ability to lead cross-functional teams and create excellent collaborationExperience leading continuous improvement projectsChange Management experience of programs with significant strategic importanceWork location: Onsite in Columbia, MOTravel: May include up to 15% domesticRelocation Assistance: May be authorizedMust 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 $183,301 - $224,034, 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-RewardsResponsibilities 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.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.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.Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.Solventum Global Terms of Use and Privacy StatementCarefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with theterms.