Senior Engineer - Juncos, PR

1. C&Q Strategy & Planning * 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. 2. Commissioning Activities * *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. 3. Qualification Execution (IQ/OQ/PQ) 4. Documentation & Compliance 5. Risk Management & Change Control 6. Cross-functional Coordination 7. Characterization Process * Author, review, and approve qualification protocols (IQ, OQ, PQ). * Ensure traceability from User Requirements Specifications (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 internal 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, Quality Assurance (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 * Doctorate OR -Masters + 2 years of Engineering experience OR * Bachelors in Engineering + 4 years of Engineering experience. Pay: $40.00 - $55.00 per hour Work Location: In person