Validation Engineer
Anasco, PR, US
Engineering
Bachelors Degree
Full Time, Temporary
1
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Anasco, PR, US
1
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team. Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management. Generation of validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports. Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Review and approve validations and completion reports for new and existing computer and automation systems. Troubleshooting computer and automation systems that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
4-6 years of experience. Bachelor’s degree is required.
10061746
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