Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, one of our clients in the Medical Device sector is looking to hire a EUMDR Validation Support position in Jacksonville, Florida.
Please note: Visa sponsorship is not available for this position. We do not accept C2C, engagements or submissions from third‐party agencies.
Job Description and Qualification:
- 5 -10+ years of Validation Life Cycle or Computer systems validation (CSV) experience within manufacturing systems.
- Experience authoring, reviewing and approving validation lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTM.
- Experience developing Periodic Review assessments, including gathering required data, evaluation of data and write and approve the periodic review report.
- Develop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systems.
- Knowledge of regulatory requirements and standard best practices, including EUMDR Compliance.
- Write and provide support deviations, discrepancies and change control documentation.
- Proficient in technical writing skills
Job Types: Full-time, Contract
Experience:
- Validation: 3 years (Required)
- Medical device: 5 years (Required)
Location:
- Jacksonville, FL 32245 (Required)
Work Location: In person
