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Validation Engineer III
Ref No.: 18-16247
Location: San Diego, California
• Three (3) level III Validation Engineers, seeking technical backgrounds in Facility and Utilities Commissioning, Process Engineering, Manufacturing Engineering, Process Chemistry and/or Analytical Chemistry.

10+ years of experience

This position is responsible for ensuring validations are addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines Provides support for process validation including new product development and legacy product manufacturing.

Tasks and responsibilities:
• Provide technical expertise and guidance for the preparation and execution of validation protocols and reports.
• Review and investigate anomalies, deviations, etc.
• Gather data and perform analysis.
• Resolves and consults on applicable validation compliance and manufacturing process issues.
• Perform technical and validation compliance reviews for protocols and reports.
• Contribute at the project team level for validation activities.
• Lead training for execution of validation protocols, and technical training as needed.
• Mentor and lead projects.
• May provide guidance to less senior staff.
• May work with hazardous materials.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred educational background:
BS degree or equivalent in engineering or related field.

Preferred experiential background:
• 10+ years of experience
• Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes.
• Knowledge of analytical and physical test methods and their respective validations.
• Comprehensive knowledge of validation documentation.
• Knowledge of federal and other regulations governing medical device assembly and design, e.g. GDP, GMP, QSR, ISO and CMDR.
• Able to work with a variety of people on multiple projects.
• Demonstrate problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office and other manufacturing systems.
• Knowledge and ability to use JMP or Minitab.
• Ability to work in a cross-functional team environment.

Tools and Equipment Used: Various test instruments, manual tools and semi-automated and automated pneumatic, mechanical and electrical equipment; computer and hazardous materials may be used. Possible exposure to Blood borne pathogens and chemicals.