Sr. Engineer (Packaging & Validation) 35333

SUMMARY

Independently leads process optimization initiatives and troubleshooting activities within manufacturing, operations, pilot plant, and capital project environments. Applies advanced engineering principles to the design, implementation, and qualification of manufacturing systems, process improvements, and capital projects. Develops, analyzes, and presents technical solutions and project results for complex engineering challenges.

EDUCATION

• Bachelor's Degree in Engineering with a minimum of four (4) years of relevant engineering experience; or
• Master's Degree in Engineering with a minimum of two (2) years of relevant engineering experience.

PREFERRED QUALIFICATIONS

Candidates should demonstrate experience in Packaging Process Engineering and Commissioning & Qualification (C&Q) , including the following:

C&Q Strategy & Planning

• Develop and implement Commissioning & Qualification strategies aligned with project objectives and regulatory requirements.
• Define system boundaries and identify direct and indirect impact systems.
• Lead risk assessments (e.g., ISPE Baseline Guide, ASTM E2500) to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasts.

Commissioning Activities

• Lead or execute commissioning activities, including FAT, SAT, and field commissioning.
• Verify systems are installed and operate according to design specifications.
• Coordinate startup activities with equipment vendors and contractors.
• Review and approve commissioning documentation and test results.

Qualification Execution (IQ/OQ/PQ)

• Author, review, and approve IQ, OQ, and PQ protocols.
• Ensure traceability from User Requirements Specifications (URS) through qualification testing.
• Execute or oversee protocol execution and ensure complete, accurate documentation.

Documentation & Compliance

• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal quality standards.
• Maintain qualification documentation within electronic document management systems.
• Support Data Integrity and ALCOA+ principles throughout qualification activities.
• Prepare validation summary reports.

Risk Management & Change Control

• Lead risk assessments supporting system qualification.
• Evaluate and manage change controls affecting validated systems.
• Assess deviations and implement appropriate CAPA actions.

Cross-Functional Collaboration

• Collaborate with Engineering, Validation, Quality Assurance, Manufacturing, and Supply Chain teams.
• Interface with system owners and technical stakeholders.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, and stakeholder communications.

Process Characterization

• Develop characterization protocols.
• Execute characterization activities.
• Analyze results and prepare characterization reports.