Validation Engineer

Validation Engineer I prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer I may require a bachelor’s degree. Typically reports to a manager or head of a unit/department. The Validation Engineer I works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer I typically requires 0-2 years of related experience.

Validation Engineer Job Description Template

Our company is looking for a Validation Engineer to join our team.

Responsibilities:

  • Lead the scheduling and execution of test plans for all levels of product testing, including CV, DV, and PV;
  • Assist in the development of detailed xVP&R plans;
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures;
  • Work with the Facility and Engineering department to support the facility;
  • Perform lab-based post-silicon validation data collection and document results;
  • Author and execute IOQ and PQ protocols and reports for equipment and computerized systems in production, QC and storage areas on site;
  • Establish critical parameters in consulation with the user department for all equipment operations and process;
  • Interface with outside test houses/vendors to execute required testing, including quoting and scheduling;
  • Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment;
  • Review the manuals of equipments and draft qualification protocols for various process and Utility equipments;
  • Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required;
  • Inititate change control and deviation processes related to qualification and regular facility and engineering activities;
  • Ensure all product issues are identified, logged, tracked, and resolved during each testing phase;
  • Develop validation and test plan documentation based on datasheets and customer use cases to reach a production worthy device;
  • Work with Design Engineering, Product Engineering, and Applications Engineering to validate new silicon products.

Requirements:

  • Proven ability to independently test/validate automotive engines – MUST have dyno experience;
  • Ability to manage challenging assignments and multiple assignments in parallel;
  • Minimum of 3 years’ experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs);
  • Experience in pharmaceutical is plus;
  • Possess excellent interpersonal, organizational, writing and communication skills;
  • IC Device Characterization;
  • Knowledge of Validation policies and documentation for various systems and processes;
  • Labview, TCL, or Python experience to work with automated test environments;
  • Reasoning ability, among others;
  • Excellent analytical and interpersonal skills;
  • Must have experience with Water systems, steam sterilizers, autoclaves;
  • Ability to perform critical analysis of situations and provide recommendations;
  • Ability and willingness to work on multiple projects at one time and be able to adapt to changing priorities;
  • Familiarity with vehicle CAN and LIN communication interfaces;
  • Familiarity with schematic design and PCB layout and prototyping concepts.