Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED

Company Description

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.

Job Description

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.  

Qualifications

• 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).

Additional Information

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.