Position SummaryThe
Senior Engineer is responsible for
leading Commissioning & Qualification (C&Q) activities for packaging systems, ensuring compliance with regulatory requirements and alignment with project objectives. This role provides technical leadership in developing strategies, executing qualification protocols, and supporting cross-functional teams throughout the project lifecycle.
Key Responsibilities
- C&Q Strategy & Planning
- Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
- Define system boundaries and classify direct and indirect impact systems.
- Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
- Develop C&Q plans, timelines, and resource forecasts.
- Commissioning Activities
- Lead and/or execute commissioning activities, including FAT, SAT, and field commissioning.
- Ensure systems are installed and operate according to design specifications.
- Coordinate with vendors, contractors, and project teams during system startup.
- Review and approve commissioning documentation and testing results.
- Qualification Execution (IQ/OQ/PQ)
- Author, review, and approve qualification protocols (Installation, Operational, and Performance Qualification).
- Maintain traceability from User Requirements Specifications (URS) through testing execution.
- Oversee protocol execution and ensure accurate documentation of results.
- Documentation & Compliance
- Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
- Manage documentation lifecycle within electronic systems.
- Apply and enforce data integrity principles (ALCOA+).
- 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 deviations and implement corrective and preventive actions (CAPA).
- Cross-functional Collaboration
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- Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
- Interface with system owners and technical authorities.
- Provide technical coaching and mentorship to junior engineers.
- Support project meetings, status updates, and stakeholder communications.
- Process Characterization
- Develop characterization protocols.
- Execute characterization studies for packaging processes.
- Prepare and review characterization reports.
Qualifications- Doctorate in Engineering, OR
- Master's degree in Engineering with 2+ years of relevant experience, OR
- Bachelor's degree in Engineering with 4+ years of relevant experience
Preferred Qualifications- Experience in packaging processes within regulated environments (pharmaceutical, biotech, or medical devices).
- Strong knowledge of GMP, FDA, EMA regulations, and industry standards.
- Familiarity with risk-based validation approaches (ASTM E2500, ISPE).
- Excellent technical writing, problem-solving, and communication skills.
