Validation Engineer (Onsite - Columbia, MO)

SOLVENTUM•Columbia, MO

4d•$106,000 - $145,750•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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 by the Corporation)
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).
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. Communicate effectively with cross functional teams.
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.
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.
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.