CQE-Certified Quality Engineer/Scientist

Validation & Engineering Group; Carolina (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Validation & Engineering Group is seeking a Quality Engineer/Scientist in Carolina, Puerto Rico. This full-time position requires CQE certification and a Bachelor's degree in Sciences or Engineering with 3-5 years of experience.

The role involves supporting the Quality Assurance program, approving manufacturing plans, validation protocols, and leading investigations. The candidate should be bilingual, have strong organizational and communication skills, and be ready to work non-standard shifts as necessary.

Qualifications

• 3 to 5 years of directly related experience in Quality Assurance and validation.
• Ability to interact with regulatory agencies.
• Strong knowledge of manufacturing and distribution processes.

Responsibilities

• Support Quality Assurance program and manage nonconformances.
• Review and approve product manufacturing plans.
• Approve validation protocols and reports for manufacturing processes.

Skills

Strong organizational skills

Strong communication (written and oral)

Bilingual (Spanish & English)

Education

Bachelor’s degree in Sciences or Engineering

Job description

Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED

• Full-time

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.
• Lead investigations.
• Support Automation activities.
• Support facilities and environmental programs.
• Approve investigations and CAPA records.
• Approve change controls.
• Bachelor’s degree Sciences o Engineering and3 to 5years of directly related experience.
• 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.

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