Validation Process Specialist
3 days ago
As a key member of our team at Solventum, you will play a crucial role in ensuring the highest standards of quality and compliance in our manufacturing processes.
The estimated salary for this position is $183,301 - $224,034 per year, depending on qualifications and experience. This compensation range includes base pay plus variable incentive pay, if eligible.
We are seeking an experienced Process Validation Leader to join our team in Columbia, MO. As a Process Validation Leader, you will be responsible for developing and executing process validation activities for medical device and drug manufacturing processes.
- Process Validation: Develop, 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 Compliance: Create 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 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.
- 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.
- 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.
- 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 succeed in this role, you will need to have a strong understanding of validation processes and regulations, as well as excellent communication and collaboration skills. A bachelor's degree or higher in a science or engineering discipline is required, along with at least 10 years of validation experience.
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