Sr Engineer

We are seeking Sr Engineer with experience in Medical Devices or Pharma industry. Duties:

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) 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.
4. Documentation & Compliance 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.
5. Risk Management & Change Control 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).
6. Cross-functional Coordination 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.
7. Characterization Process Develop the characterization protocols. Execute the characterization activities. Develop and review the characterization reports Requirements Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience Bilingual (Spanish/English)