Sr Engineer

Juncos, Puerto Rico | Posted on 10/06/2026

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

Duties:

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.


• Define system boundaries and identify direct/indirect impact systems.


• 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.

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.


• 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