Sr Engineer

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico seeks a Senior Engineer experienced in Medical Devices or Pharma to lead commissioning and qualification activities. You will define system boundaries, develop IQ/OQ/PQ plans, and coordinate with vendors to ensure compliant, validated systems.

Position entails leading documentation, risk assessments, CAPAs, and change controls, with cross-functional interaction among Engineering, QA, Manufacturing, and Supply Chain teams.

Qualifications

• Doctorate or Masters in Engineering with 2+ years of engineering experience.
• Bachelors in Engineering with 4+ years of engineering experience.

Responsibilities

• 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.

Education

Doctorate or Masters in Engineering

Bachelors in Engineering

Job description

Juncos, Puerto Rico

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