GMP Quality Engineering & Compliance Specialist

Veg Group; Puerto Rico; On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Engineering Support Specialist to provide technical and documentation support for QA Engineers responsible for facilities, assets, utilities, and maintenance processes at the PR05 site.

Ideal candidates bring 5+ years of GMP experience, strong GDP/data integrity writing, and proficiency with QA systems. The role requires bilingual English/Spanish capabilities and flexibility for 24/7 operations as needed.

Qualifications

• Minimum 5 years of experience in automated bulk pharmaceutical GMP operations.
• Comprehensive knowledge of Facilities, Utilities, Maintenance and Engineering (FUME) standards.
• Proficiency with Quality Systems and computer platforms (e.g., TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
• Knowledge and application of Good Documentation Practices (GDP) and data integrity principles, with strong technical writing.

Responsibilities

• Serve as a technical resource for initiatives and projects related to assets, utilities, and processes to support compliant deliverables.
• Support monitoring of qualified utilities performance against internal and external quality requirements and regulations.
• Support execution of maintenance, engineering, and qualification activities and strategies.
• Support event investigations and participate in Root Cause Analysis led by QA Engineers.
• Support problem solving and risk management activities.
• Support change controls development and implementation.
• Ensure assigned documentation has good technical writing and complies with GDP and data integrity requirements.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.
• Collaborate across departments to ensure alignment with regulatory expectations.

Skills

Quality systems

Data integrity

Technical writing

Cross-functional collaboration

Bilingual (English/Spanish)

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

TrackWise

Veeva QDocs

QMS

Kneat

GMARS

Job description

Validation & Engineering Group, Inc. seeks a Quality Engineering Support Specialist to provide technical and documentation support for QA Engineers responsible for facilities, assets, utilities, and maintenance processes at the PR05 site.

Ideal candidates bring 5+ years of GMP experience, strong GDP/data integrity writing, and proficiency with QA systems. The role requires bilingual English/Spanish capabilities and flexibility for 24/7 operations as needed.