GMP-Driven 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. 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.