Validation Engineer

3 weeks ago


Chicago, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
  • Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipment/components.
  • Develop Commissioning and Qualification Plans.
  • Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211 and adherence to ICH Q7.
  • Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
  • Lead discussions and provide guidance to personnel during risk assessments.
  • ssure adherence to Q9 "Quality Risk Management".
  • ssure Compliance with FDA and EU Regulations.
  • Evaluate, document, and develop investigations attributed to qualifications failures.
  • uthor Summary Reports, events, and applicable protocol amendments.
  • Execute and/or provide support during protocol executions.
  • ssure all the qualification items are tracked and successfully completed.
  • Perform GAP analysis and provide recommendations for existing qualifications.
  • bility to work in a fast pace, team-oriented environment.
  • Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
  • Potential to manage engineering projects from design through qualification, depending on candidates experience and skill set.
  • Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.
  • Complies with all company policies and standards
  • Performs other functions as required or assigned
Requirements:
  • BS or MS Degree in related Engineering field.
  • t Least 4 Years of experience in automated systems, project management is a plus.
  • t least 2 years' experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.

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