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.
Show the full description
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%
