The Role
Develop and execute commissioning and qualification strategies for pharmaceutical or medical device systems. Lead risk assessments, FAT, SAT, field commissioning, IQ/OQ/PQ protocols, characterization activities, documentation, change controls, deviations, and CAPA. Ensure compliance with GMP, FDA, EMA, data integrity, and ALCOA+ requirements. Coordinate with engineering, validation, quality, manufacturing, supply chain, vendors, and system owners while mentoring junior engineers.
Summary Generated by Built In
We are seeking Sr Engineer with experience in Medical Devices or Pharma industry.
Duties:
1. 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.
2. 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.
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.
5. 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).
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 - Bilingual (Spanish/English)
Skills Required
- Doctorate in Engineering
- At least 2 years of Engineering experience with a Master's degree in Engineering
- Bachelor's degree in Engineering with at least 4 years of Engineering experience
- Bilingual in Spanish and English
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
