Senior Process Validation Engineer

Inteldot; Puerto Rico; On-site; USD 90,000 - 140,000; Full time

Job summary

Inteldot, a life sciences partner, seeks an Administrative Shift specialist for a major client in Puerto Rico. You will lead commissioning and qualification activities across GMP-regulated environments, aligning with project and regulatory requirements.

The role requires deep knowledge of CQ, FAT/SAT, IQ/OQ/PQ protocols, risk assessments, and cross-functional collaboration with Engineering, QA, Manufacturing and Supply Chain teams.

Qualifications

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with GMP/GLP documentation in a regulated environment.
• Ability to operate specialized laboratory equipment and computers.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Develop solutions to routine technical problems of limited scope.

Responsibilities

• Develop and implement 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.
• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from URS through testing.
• Execute or oversee protocol execution and ensure proper documentation of results.
• Ensure all C&Q documentation complies with GMP, FDA, EMA, and Amgen standards.
• Maintain document lifecycle within electronic systems.
• Support data integrity and ALCOA+ principles throughout qualification activities.
• Prepare and support validation summary reports.
• Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess impact of deviations and implement corrective and preventive actions (CAPA).
• Collaborate with Engineering, Validation, QA, Manufacturing, and Supply Chain teams.
• Interface with system owners and technical authorities.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, and stakeholder communication.
• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports

Skills

Pharmaceutical processes

Validation familiarity

Regulated documentation

Laboratory equipment operation

GMP/GLP knowledge

Engineering problem solving

Education

Doctorate

Masters + 2 years

Bachelor in Engineering

Job description

Inteldot, a life sciences partner, seeks an Administrative Shift specialist for a major client in Puerto Rico. You will lead commissioning and qualification activities across GMP-regulated environments, aligning with project and regulatory requirements.

The role requires deep knowledge of CQ, FAT/SAT, IQ/OQ/PQ protocols, risk assessments, and cross-functional collaboration with Engineering, QA, Manufacturing and Supply Chain teams.