Quality Engineering Support Specialist

Job overview

The Quality Engineering Support Specialist works onsite at the PR05 site in Puerto Rico; the listing gives the location as 00983, PR. Compensation is not specified. The role provides technical and documentation support to Lilly QA Engineers responsible for facilities, assets, utilities, and maintenance processes. The specialist supports compliant engineering and quality work by monitoring qualified utilities, assisting with maintenance and qualification activities, and contributing to investigations, risk management, and change controls. Accurate technical documentation and timely escalation of significant quality issues help the QA team maintain quality requirements and data integrity.

What you'll do

• Provide technical support for asset, utility, and process initiatives
• support monitoring of qualified utilities against quality requirements and regulations
• assist with maintenance, engineering, and qualification activities
• support event investigations and root-cause analysis led by QA Engineers
• assist with problem-solving, risk management, and change controls
• prepare assigned documentation in accordance with Good Documentation Practices and data-integrity requirements
• notify QA or Quality management of significant issues.

What we're looking for

Skills & competencies

quality engineering

pharmaceutical gmp

qa support

facilities

utilities

maintenance

change control

good documentation practices

data integrity

english and spanish

pr05 site

puerto rico

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in engineering and at least five years of experience in automated bulk pharmaceutical GMP operations; bilingual English and Spanish communication skills are required. May need to support irregular hours, shift rotations, weekends, holidays, or emergencies for 24/7 operations.

About the employer

Validation & Engineering Group, Inc is hiring for this role. Industry: Engineering Services. Sector: 54.