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Validation and Process Specialist
2 months ago
Job Summary:
We are seeking a highly skilled and detail-oriented Validation and Process Specialist to play a critical role in ensuring that equipment and processes meet the highest standards of quality and compliance.
- Equipment Validation and Qualification:
- Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.
- Ensure that all validation activities comply with industry standards and regulatory requirements.
- Test Method Validation and Process Characterization:
- Create and implement test method validation protocols to ensure reliable and reproducible testing methods.
- Collaborate with quality, R&D, and manufacturing teams to ensure accurate execution and results analysis.
- Process Optimization and Design of Experiments:
- Perform process characterization and identify key process variables that influence performance.
- Design, execute, and analyze experiments using Design of Experiments (DoE) methodologies to optimize processes and equipment performance.
- Ensure all documentation is current and aligns with company standards and regulatory guidelines.
- Prepare detailed validation reports and ensure that all findings, data, and results are properly documented.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3+ years of experience in equipment validation, process characterization, or a similar role in the medical device, pharmaceutical, or manufacturing industry.
- Experience with Test Method Validation (TMV) and statistical analysis.
- Knowledge of PLM systems and Change Order (CO) processes.
Preferred Qualifications:
- Experience in regulated industries such as medical devices or pharmaceuticals.
- Knowledge of ISO 13485, FDA regulations, or other relevant regulatory standards.
- Proficiency in software tools like Minitab, JMP, or similar for statistical analysis.
- Ability to work independently and take ownership of complex projects.
- High attention to detail and a commitment to producing quality work.
