Validation Specialist

Full time
Dorado, Puerto Rico

We are looking for Validation Specialist with great aptitude, leadership and character to learn and complete important projects with our pharmaceutical clients in Puerto Rico. This is a learning opportunity full of new experiences and challenges with high innovative technologies.

Responsibilities may vary from:

1.Plan, develop, and implement documentation, procedures, and trainings necessary for the engineering team.

2.Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports.

3.Manufacturing processes transference validations and related activities.

4.Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

5.Troubleshooting processes that do not perform as intended during validation runs.

6.Recommend process/quality improvements as part of validation runs.

7.Work with new and existing equipment, processes, utilities, facilities and cleaning validations.

8.Evaluate, investigate and document non-conformance incidents and/or protocol deviations.

9.Prepare information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc.

10. Other related duties necessary in the job site.

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