Global QA Engineering Lead — GMP & Compliance

Validation & Engineering Group; Barceloneta (PR); On-site; USD 130,000 - 170,000; Full time

Job summary

Validation & Engineering Group is seeking a Quality Assurance Engineering Lead to oversee QA for global engineering programs, including biologics, aseptic manufacturing, and medical devices. The role ensures GMP compliance and risk mitigation across design and qualification lifecycles.

The ideal candidate will guide design reviews, participate in SRAs, and coordinate with site quality teams to maintain schedules and quality deliverables in a fast-paced environment.

Qualifications

• Bachelor’s or Master’s in Engineering or Science required.
• 8+ years in Quality Assurance Engineering or related pharma roles.
• Strong GMP knowledge and ability to manage design and qualification activities.

Responsibilities

• Provide QA governance and oversight for global engineering programs.
• Review facility utility and equipment design through GMP qualifications.
• Lead contamination control risk assessments across sites and functions.
• Develop contamination control strategies for global engineering programs.

Skills

Quality Assurance

Regulatory Compliance

GMP Knowledge

Cross-functional Collaboration

Communication Skills

Project Oversight

Education

Bachelor’s or Master’s in Engineering or Science

Tools

GMP Documentation

Risk Management

Job description

Validation & Engineering Group is seeking a Quality Assurance Engineering Lead to oversee QA for global engineering programs, including biologics, aseptic manufacturing, and medical devices. The role ensures GMP compliance and risk mitigation across design and qualification lifecycles.

The ideal candidate will guide design reviews, participate in SRAs, and coordinate with site quality teams to maintain schedules and quality deliverables in a fast-paced environment.