Validation Engineer (Onsite - Columbia, MO)

United States·Columbiamid

QA & TestingValidation Engineer

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

Thank you for your interest in joining Solventum.

Technical Tools

QA & TestingValidation Engineer

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.

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.

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

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 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.

Carefully 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. Before submitting your application you will be asked to confirm your agreement with the
terms.