The Role
Lead development and execution of commissioning and qualification strategy for packaging systems. Oversee FAT/SAT/field commissioning, author and approve IQ/OQ/PQ protocols, ensure URS traceability, maintain GMP/FDA/EMA compliance and ALCOA+ data integrity, manage risk assessments and change control, coordinate cross-functional teams, and mentor junior engineers.
Summary Generated by Built In
We are seeking a Sr. Engineer to develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
1. Commissioning & Qualification Strategy and 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 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 engineering experience or, Bachelor’s in engineering + 4 years of Engineering experience.
- Packaging Process experience.
- Bilingual (English and Spanish, written and spoken).
Skills Required
- Doctorate in engineering OR Master's degree plus 2 years engineering experience OR Bachelor's degree plus 4 years engineering experience
- Packaging process experience
- Bilingual English and Spanish, written and spoken
- Experience with commissioning activities (FAT, SAT, field commissioning)
- Experience authoring and executing qualification protocols (IQ, OQ, PQ) and ensuring URS traceability
- Knowledge of GMP, FDA, EMA regulatory requirements and ALCOA+ data integrity principles
- Experience conducting risk assessments (e.g., ISPE Baseline, ASTM E2500), change control, CAPA
- Experience maintaining C&Q documentation within electronic systems
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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.
