Validation Engineer - Temperature Mapping

North Chicago, IL 60154

Employment Type: Permanent Job Category: Validation Job Number: AD797281614 Compensation: $80,000 / year

Job Description

Job Overview:

The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes. 


  • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Qualification Policies.
  • Initiate 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, as well as adherence to ICH Q7.
  • Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
  • Assure Compliance with FDA and EU Regulations.
  • Evaluate, document, and develop investigations attributed to qualifications failures.
  • Author Summary Reports, events, and applicable protocol amendments.
  • Execute and/or provide support during protocol executions.
  • Assure all the qualification items are tracked and successfully completed.
  • Perform GAP analysis and provide recommendations for existing qualifications.
  • Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)

Preferred/Required Education/Skills:

  • Bachelor’s or Master's degree in Engineering, Science, or a related field.
  • 3+ years of experience with commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies. Temperature mapping is a plus 
  • Pharmaceutical, healthcare, or medical device industry experience is a plus

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

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