Sr Engineer

QRC; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QRC Group, LLC is seeking a Senior Engineer with extensive experience in Medical Devices or Pharmaceuticals to lead commissioning and qualification activities. You will define and execute C&Q strategies, manage risk assessments, and ensure regulatory compliance across GMP, FDA, and EMA requirements.

This role involves collaboration with Engineering, QA, Manufacturing, and Supply Chain. The ideal candidate holds an engineering doctorate or master's degree with relevant experience, or a bachelor's

Qualifications

• Doctorate or Masters degree with engineering experience (2+ years) or a Bachelor's degree with engineering experience (4+ years).
• Fluency in Spanish and English is required for communication with multidisciplinary teams.

Responsibilities

• Lead C&Q strategy and planning for medical devices/pharma projects.
• Coordinate commissioning activities including IQ/OQ/PQ and FAT/SAT execution.
• Review qualification protocols and ensure traceability from URS to testing.
• Ensure GMP, FDA, EMA compliance and ALCOA+ data integrity across documents.

Skills

Bilingual Spanish/English

Education

Doctorate or Masters in Engineering

Bachelor's in Engineering

Job description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

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

Duties

• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• Characterization Process
• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports

Qualifications

Requirements

• Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience
• Bilingual (Spanish/English)

Additional Information

All your information will be kept confidential according to EEO guidelines.