Senior C&Q Engineer – GMP/Pharma

Inteldot; Juncos (PR); On-site; USD 95,000 - 140,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift engineer to lead commissioning and qualification activities for pharma/biotech projects. You will design strategies, coordinate with validation, QA, manufacturing, and engineering teams, and ensure compliance with GMP/FDA standards.

The role requires advanced engineering knowledge, experience with IQ/OQ/PQ, risk assessments, and the ability to manage documentation lifecycle in validated systems.

Qualifications

• Pharma/biotech processes knowledge required.
• Familiarity with validation processes.
• Experience with GMP/GLP documentation.
• Operate lab equipment and computers.
• Interpret and apply GLPs and GMPs.
• Apply engineering science to production.
• Develop solutions to routine technical problems.

Responsibilities

• Develop and implement commissioning & qualification strategy.
• Define system boundaries and assess impact.
• Lead risk assessments (ISPE Baseline, ASTM E2500).
• Develop C&Q plans, schedules, resources.
• Oversee FAT, SAT, and field commissioning.
• Review qualification documentation and test results.
• Prepare and approve IQ/OQ/PQ protocols.
• Ensure traceability from URS through testing.
• Maintain GMP/FDA/EMA compliant documentation.
• Collaborate with Engineering, Validation, QA, Manufacturing and Supply Chain.
• Mentor junior engineers and project team members.
• Interface with system owners and technical authorities.
• Support project meetings and stakeholder communication.
• Develop the characterization protocols/reports.

Skills

Pharma processes

Validation processes

Regulated documentation

Lab equipment

GLP/GMP knowledge

Engineering in production

Problem solving

Education

Doctorate

Masters + 2 years

Bachelor + 4 years

Job description

Inteldot in Puerto Rico seeks an Administrative Shift engineer to lead commissioning and qualification activities for pharma/biotech projects. You will design strategies, coordinate with validation, QA, manufacturing, and engineering teams, and ensure compliance with GMP/FDA standards.

The role requires advanced engineering knowledge, experience with IQ/OQ/PQ, risk assessments, and the ability to manage documentation lifecycle in validated systems.