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Validation & Engineering Group

Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED

Carolina, PR · On-site · Full-time

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About the role

Project ManagementComplianceQuality AssuranceSpanish
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA. Support Quality Assurance program: - Non Conformances - Review and approve product MPs. - Approve validation protocols and reports for manufacturing processes.  - Approve Environmental Characterization reports. - Lead investigations. - Review Risk Assessments. - Support Automation activities. - Support facilities and environmental programs. - Approve investigations and CAPA records. - Approve change controls.     - Bachelor’s degree Sciences o Engineering and 3 to 5 years of directly related experience. - Project management skills. - Strong organizational skills. - Strong knowledge in area of expertise. - Collaborate and coordinate with higher level outside resources. - Strong knowledge of and experience with processes involved in manufacturing and distribution. - Validation and process development. - Demonstrate ability to interact with regulatory agencies. - Strong word processing, presentation, database and spreadsheet application skills. - Strong communication (both written and oral), facilitation and presentation skills. - Ability to evaluate compliance issues. - Available to work non-standard shifts requested. - Fully Bilingual (Spanish & English).      Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.