Position Overview
The Senior Engineer will provide technical leadership and hands-on engineering support for process validation and packaging systems characterization, with a strong emphasis on packaging operations. This role is critical to ensuring that packaging processes, equipment (including cartoners), and systems are fully characterized, validated, and compliant with GMP and regulatory requirements. The engineer will play a key role in Drug Product packaging operations, supporting process validation, equipment qualification, packaging characterization, and product transfer activities, while collaborating with cross-functional teams including Manufacturing, Quality, Automation, and Supply Chain.

Key Responsibilities
Validation & Engineering Activities
• Lead and execute Commissioning, Qualification, and Validation (IQ/OQ/PQ / PPQ) for packaging and manufacturing equipment.
• Develop and execute validation protocols and reports, ensuring full lifecycle compliance.
• Perform and lead packaging process characterization studies, defining process capability, critical parameters, and operational ranges.
• Support equipment qualification activities, including cartoners, labeling systems, and automated packaging systems.
• Ensure validation strategies align with site validation master plans and regulatory expectations.

Packaging & Process Characterization (Critical Focus)
• Provide technical expertise in packaging operations, including cartoning equipment, labeling, serialization, and inspection systems.
• Lead packaging equipment characterization, including performance evaluation, efficiency, and process robustness.
• Support troubleshooting and technical investigations related to packaging processes and equipment.
• Evaluate and optimize packaging systems using data-driven and risk-based approaches (DOE, FMEA).
• Support New Product Introduction (NPI) and technology transfer activities with strong focus on packaging readiness.

Cross-Functional Collaboration
• Partner with Manufacturing, Quality, Automation, and Supply Chain teams to support execution and validation readiness.
• Participate in risk assessments (FMEA) and validation strategy development.
• Provide technical support during audits, inspections, and regulatory interactions.
• Support training and knowledge transfer for new processes, equipment, and validated systems.
Additional Responsibilities
• Support continuous improvement initiatives focused on packaging efficiency, yield, and reliability.
• Analyze process performance data and recommend improvements to enhance operational performance.
• Lead or support capital projects, equipment upgrades, and system improvements.

Basic Qualifications
• Bachelor's Degree in Mechanical, Electrical, Industrial, or Chemical Engineering
• Minimum 5+ years of experience in packaging engineering within regulated industries (pharma/biotech/medical devices)
• Strong hands-on experience in process validation and packaging systems characterization

Preferred Qualifications
• Proven experience with packaging equipment, especially cartoners (cartoneras)
• Strong expertise in validation lifecycle (IQ/OQ/PQ/PPQ) and process characterization
• Experience supporting technology transfer, NPI, and packaging line implementation
• Knowledge of GMP, FDA regulations, and validation frameworks
• Experience with automation systems, serialization, and vision inspection technologies
• Strong technical writing and documentation skills

Key Technical Skills
• Packaging Process Characterization
• Validation Lifecycle (IQ/OQ/PQ / PPQ)
• Cartoning Equipment (Cartoneras) & Packaging Systems
• GMP / FDA Compliance
• Change Control & Deviation Management
• Root Cause Analysis & CAPA
• Risk Management (FMEA)
• Technical Documentation & Protocol Authoring