Senior Engineer — Pharma C&Q & Validation

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico/USA, focusing on Commissioning & Qualification of pharmaceutical systems. You will develop and execute IQ/OQ/PQ protocols, lead risk assessments, and ensure traceability from URS to testing.

Responsibilities include coordinating with engineers, QA, and vendors, implementing GMP/GxP standards, and maintaining compliant documentation across C&Q activities in a highly regulated environment.

Qualifications

• Bachelor’s degree in Engineering required.
• 4+ years of Engineering experience.
• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with documentation in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.
• Negotiation, persuasion and facilitation.

Responsibilities

• Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues.
• Applies engineering principles to design and implementation of major system modifications and projects.
• Develop and implement the overall Commissioning & Qualification strategy.
• Lead risk assessments to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.
• Commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems operate per design specifications; coordinate with vendors during startup.
• Review and approve commissioning documentation and test results.
• Execute or oversee IQ/OQ/PQ protocols and ensure traceability from URS to testing.
• Maintain GMP/ FDA/ EMA compliance and document lifecycle.

Skills

GLPs & GMPs

Documentation

Leadership

Collaboration

Vendor management

Problem solving

Negotiation

Communication

Project cost

Team mentoring

Education

Bachelor’s degree in Engineering

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico/USA, focusing on Commissioning & Qualification of pharmaceutical systems. You will develop and execute IQ/OQ/PQ protocols, lead risk assessments, and ensure traceability from URS to testing.

Responsibilities include coordinating with engineers, QA, and vendors, implementing GMP/GxP standards, and maintaining compliant documentation across C&Q activities in a highly regulated environment.