Quality Engineering Support Specialist

Veg Group; Carolina (PR); On-site; USD 60,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Engineering Support Specialist for the PR05 site in Puerto Rico.

You will provide technical and documentation support to QA engineers, focusing on facilities, utilities, maintenance, and qualification activities to ensure regulatory compliance and data integrity. You must be bilingual (English/Spanish) and ready to support 24/7 operations when required, with established experience in GMP environments and GDP practices.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical).
• Minimum five years in automated GMP operations with facilities, utilities, maintenance, and quality systems.
• Strong writing and knowledge of GDP and data integrity.

Responsibilities

• Serve as a technical resource for assets, utilities, and processes to support compliant deliverables.
• Monitor qualified utilities performance against quality requirements and regulations.
• Support maintenance, engineering, and qualification activities and strategies.
• Assist investigations and root cause analysis led by QA engineers.
• Support change controls development and implementation.
• Ensure documentation meets GDP and data integrity requirements.
• Notify QA management of significant quality issues promptly.

Skills

Quality Systems

Technical Writing

GDP/Data Integrity

Bilingual English/Spanish

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

TrackWise

Veeva QDocs

QMS

Kneat

GMARS

Job description

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Engineering Support Specialist

The Quality Engineering Support Specialist provides technical and documentation support to Lilly QA Engineers responsible for facilities, assets, utilities, and maintenance processes at the PR05 site.

Description:

Technical & Compliance Support

• Serve as a technical resource for initiatives and projects related to assets (equipment/facilities), 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 Good Documentation Practices (GDP) and data integrity requirements.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.

Qualifications:

Education

• Bachelor’s Degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical).

Experience

• At least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems.
• Comprehensive knowledge of Facilities, Utilities, Maintenance and Engineering (FUME) standards.
• Proficiency with Quality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
• Knowledge and application of Good Documentation Practices (GDP) and data integrity principles, with strong technical writing.

Core Competencies & Behavioral Expectations

• Establishes positive interpersonal relationships and interacts effectively across departments, internally and externally.
• Organizes and prioritizes multi-functional tasks and works effectively under time and schedule pressure.
• Exercises sound judgment, is assertive when required, and works effectively under minimal supervision.
• Communicates effectively at all levels with strong decision-making capability.

Additional Requirements

• Bilingual (English and Spanish) with strong verbal, written, and technical communication skills.
• Flexibility to support a 24/7 operation when required (irregular hours, shift rotations, weekends, holidays, emergencies).
• Complete required Quality, Safety, and Environmental trainings (including the Code of Conduct) and cGMP/SOP training on onboarding; qualifications documented per 21 CFR 211.25.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.