Validation Engineer
Job in
Fall River, Bristol County, Massachusetts, 02720, USA
Listed on 2026-05-31
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Pharma Engineer, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Validation Engineer responsible for supporting validation activities for manufacturing equipment, processes, and systems within a medical device manufacturing environment while ensuring compliance with regulatory and quality standards.
Required Qualifications- Bachelor’s degree in Engineering or related field
- 3+ years of Validation Engineering experience in the medical device or healthcare industry
- Experience with equipment validation, process validation, and IQ/OQ/PQ protocols
- Knowledge of GMP, FDA, and ISO 13485 regulations
- Experience with CAPA, deviation investigations, and root cause analysis
- Strong documentation and technical writing skills
- Execute validation activities for manufacturing equipment, processes, and systems
- Develop and review IQ/OQ/PQ protocols and validation reports
- Support deviation investigations and implement corrective actions
- Ensure validation activities comply with regulatory and quality standards
- Collaborate with Manufacturing, Quality, and Engineering teams on validation projects
- Maintain validation documentation and support continuous improvement initiatives
- Experience in cleanroom or regulated manufacturing environments
- Familiarity with risk assessments and statistical analysis tools
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