Sr Engineer

QRC Group; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico is seeking a Senior Engineer with experience in Medical Devices or Pharma. You will lead commissioning and qualification activities to ensure systems meet design and regulatory requirements.

Duties include developing C&Q strategies, defining system boundaries, executing IQ/OQ/PQ, and coordinating with vendors. You will mentor junior engineers and document results in GMP-compliant records.

Qualifications

• PhD or MSc with 2+ years engineering experience or a BS with 4+ years.
• Strong understanding of GMP/FDA/EMA standards relevant to medical devices.
• Experience in commissioning, validation, and data integrity practices.

Responsibilities

• Develop and implement Commissioning & Qualification strategy aligned with project and regulatory needs.
• Define system boundaries and identify affected systems.
• Create C&Q plans, schedules and resource forecasts.
• Oversee commissioning activities including FAT, SAT, field commissioning.
• Ensure installed systems operate per design specifications and approve test results.
• Coordinate with vendors and contractors during startup activities.
• Review and approve qualification protocols and maintain traceability from URS to testing.
• Support risk assessments, change controls, and CAPAs related to qualification.

Skills

Engineering experience

Regulatory knowledge

GMP/FDA understanding

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Tools

IQ/OQ/PQ protocols

Qualification execution

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