Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED

Validation & Engineering Group; Carolina (PR); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

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

Kenntnisse

Strong organizational skills

Strong communication (written and oral)

Bilingual (Spanish & English)

Ausbildung

Bachelor’s degree in Sciences or Engineering

Jobbeschreibung

Quality Engineer/ Scientist – CQE CERTIFICATION REQUIRED

Full‑time position.

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, and Validation across Puerto Rico and the USA.

Support Quality Assurance program:

• Nonconformances
• Review and approve product manufacturing plans (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

Qualifications:

• Bachelor’s degree in Sciences or Engineering and 3 to 5 years of directly related experience
• Strong organizational skills
• Strong knowledge in area of expertise
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of processes involved in manufacturing and distribution
• Experience with validation and process development
• Ability to interact with regulatory agencies
• Strong word‑processing, presentation, database, and spreadsheet application skills
• Strong communication (written and oral), facilitation and presentation skills
• Ability to evaluate compliance issues
• Availability to work non‑standard shifts as requested
• Fully bilingual (Spanish & English)

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