Validation Specialist
hace 2 semanas
About the Job
At Gsb, we are seeking a skilled Validation Specialist to join our team. The ideal candidate will have experience in process and equipment validation in the Medical Devices industry.
Key Responsibilities
- Conduct meetings to develop strategies and solutions with cross-functional teams.
- Guide the validation process, lead the draft and review of protocols and test reports.
- Offer onsite support during the execution phase of validations (IQ, OQ, PQ).
- Draft validation strategies, including TMVs.
- Qualify first articles, complete process capability studies, and process validation on internal and supplier processes using statistical techniques.
- Support change management activities using the organization's PLM tool.
- Prepare reports as per project requirements.
- Supervise, coordinate, and technically revise the work of a limited group of technicians.
- Ensure subordinates follow company guidelines related to Health, Safety, and Environmental practices.
- Communicate business-related issues or opportunities to the next management level.
- Ensure personal and company compliance with federal, state, local, and company regulations, policies, and procedures.
Requirements
- 4+ years of experience with demonstrated proficiency in process/equipment validation and providing ongoing technical support.
- Work experience in the Medical Device industry.
- Advanced English language skills.
Benefits
Courses and certifications.
9-month project with the possibility of extension.
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