Senior Engineer Validation

Work Flexibility: Hybrid

What you will do:

• Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements.
• Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing.
• Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up . Should have strong understanding of the difference between verification and validation.
• Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports.
• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems.
• Support Master Validation Planning and validation lifecycle management activities.
• Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.

What you will need:

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
• Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or a related discipline within medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems.
• Experience with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation.
• Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations.
• Strong understanding of GMP, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 60601, and risk management principles.

Preferred Qualification:

• Experience with PFMEA, Control Plans, PPAP, and process qualification methodologies.
• Working knowledge of MSA, Gage R&R, process capability analysis, and statistical tools such as Minitab.
• Experience supporting New Product Development (NPD), design transfer, and manufacturing scale-up activities.
• Strong problem-solving, project management, and technical documentation skills.
• Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams.

 

Travel Percentage: 20%