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)