Validation Engineer

Job Responsibilities:

Perform equipment qualification/validations such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and manufacturing process validations, including developing validation master plans, preparing protocols, analyzing test results, and preparing technical reports. Collaborate with Research and Development (R&D) and other cross functional teams as necessary to ensure stakeholder engagement and alignment with risk management processes: identify hazards/failure modes associated with medical devices, and estimate, evaluate, control, and document (Failure Modes and Effects Analysis (FMEAs)) associated risks. Identify root cause for issues and develop corrective and preventive actions (CAPAs). Develop standard operating procedures (SOPs) and work instruction (WI) for equipment usage, processes, calibration, and preventive maintenance as required. Conduct research that tests or analyzes the feasibility, operation, or performance of equipment, components, or parts using applicable Test Method Validations (TMVs). Coordinate validation activities with, and seek team support from, Project Management, Manufacturing, Engineering, and other groups on validation projects to ensure validation projects are carried out on time and on budget. Determine machine and/or process capability through planning and executing process capability studies. Review and approve Engineering Change Controls (ECC). Maintain up-to-date knowledge of validation requirements, practices, and procedures across the industry. Collect, analyze, and present data for key metrics using statistical methodology to monitor performance of processes during Quality Management Review. Manage validation records in an electronic database system. Support internal, regulatory, and client audits, and audit company sites as needed. Assure compliance with all in-house or external specifications to standards, such as International Organization for Standardization (ISO), Food and Drug Administration (FDA), and Good Manufacturing Practice (GMP) regulations. 10-20% domestic travel required.

Key Qualifications:

• Bachelor's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field
• Five (5) years of experience as a Equipment Quality Engineer, Quality Engineer, or related occupation in an FDA regulated industry.
• Must have experience with the following:
  • Food and Drug Administration (FDA) regulated medical device regulations (1 CFR 11, 1 CFR 8 , ISO 13485);
  • Analyzing potential gaps in products or processes to determine root cause and corrective action (CAPA) and Non-Conformances;
  • Validation methodologies and principles: Equipment Validation (IQ, OQ, and PQ), Manufacturing Process Validation (IQ, OQ, PQ, and Process Capability), and special process validation (sterilization and cleaning); 
  • TMVs: Gauge repeatability and reproducibility (GR&R), and test equipment validations;
  • Risk management and application of Failure Modes and Effects Analysis (FMEA) to validations; 
  • Using statistical techniques for trending key performance indicators (KPIs) and key performance metrics (KPMs).

Alternate Education and Experience:

• Master’s degree or foreign equivalent in in Mechanical Engineering, Industrial Engineering, Biomedical Engineering
• Three (3) years of experience as a Equipment Quality Engineer, Quality Engineer, or related occupation in an FDA regulated industry.