Quality Engineering Support Specialist

Validation & Engineering Group, Inc.; Carolina (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a Quality Engineering Support Specialist to provide technical and documentation support to Lilly QA Engineers overseeing facilities, utilities, and maintenance processes at the PR05 site.

The role requires a Bachelor's in Engineering and at least five years in automated bulk pharmaceutical GMP operations, with GDP and data integrity focus; strong communication and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in Engineering as specified.
• At least five years of experience in automated bulk pharmaceutical GMP operations.
• Knowledge of GDP and data integrity principles.

Responsibilities

• Provide technical and documentation support to QA engineers for facilities, assets, and maintenance.
• Monitor qualified utilities performance against quality requirements and regulations.
• Assist maintenance, engineering, qualification activities and strategies.

Skills

Interpersonal communication

Verbal and written communication

Technical writing

Time management under pressure

Education

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

Tools

Microsoft Office

TrackWise

Veeva QDocs

QMS

Kneat

GMARS

Job description

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

Investigation, Documentation & Change Control Support

• 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.

Technical Competencies

• 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.