Sr Engineer

QRC Group•Juncos, PR

12d

About The Position

We are seeking a Sr Engineer with experience in the Medical Devices or Pharma industry. This role involves developing and implementing Commissioning & Qualification (C&Q) strategies, overseeing commissioning activities, executing qualification protocols (IQ/OQ/PQ), ensuring compliance with regulatory standards, managing risks and change controls, coordinating with cross-functional teams, and developing characterization protocols and reports.

Requirements

Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience
Bilingual (Spanish/English)
Experience in Medical Devices or Pharma industry

Responsibilities

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.
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 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