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.
Excited to build something meaningful together? We look forward to hearing from you.
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.
Skills Required
- Bachelor’s degree in Chemical, Biotechnical, Biomedical, or Mechanical Engineering
- At least five years of experience in automated bulk pharmaceutical GMP operations, including Production, Engineering, QA, or Technical Services
- Understanding of facilities, utilities, maintenance, commissioning and qualification, and quality systems
- Comprehensive knowledge of Facilities, Utilities, Maintenance and Engineering standards
- Proficiency with Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, or GMARS
- Knowledge and application of Good Documentation Practices and data integrity principles
- Strong technical writing skills
- Bilingual English and Spanish verbal, written, and technical communication skills
- Flexibility to support 24/7 operations, including irregular hours, shift rotations, weekends, holidays, and emergencies
- Completion of required Quality, Safety, Environmental, Code of Conduct, cGMP, and SOP training
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
