Senior C&Q Engineer - GMP Validation Leader

Integrated Services For Productivity & Validation, Inc; Juncos (PR); On-site; USD 100,000 - 150,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a senior professional to lead Commissioning & Qualification activities in Juncos, PR. The role focuses on defining boundaries, advancing risk assessments, and coordinating FAT/SAT activities to ensure systems meet design specs and regulatory standards.

You will author and review IQ/OQ/PQ protocols, maintain traceability from URS to testing, and support CAPA and change controls within a GMP/regulated environment.

Qualifications

• Doctorate in Engineering or Masters with 2 years of Engineering experience.
• Bachelor in Engineering with 4 years of Engineering experience.
• Experience with GMP, FDA, EMA or equivalent regulatory standards is preferred.

Responsibilities

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results.

Education

Doctorate

Masters in Engineering

Bachelor's in Engineering

Job description

Integrated Services For Productivity & Validation, Inc is seeking a senior professional to lead Commissioning & Qualification activities in Juncos, PR. The role focuses on defining boundaries, advancing risk assessments, and coordinating FAT/SAT activities to ensure systems meet design specs and regulatory standards.

You will author and review IQ/OQ/PQ protocols, maintain traceability from URS to testing, and support CAPA and change controls within a GMP/regulated environment.