Validation Specialist

Validation Specialist Job Description Template

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

Responsibilities:

  • Ability to work in a cross functional group as needed to resolve general equipment or manufacturing deficiencies;
  • Assess impact of process / equipment or procedural changes that can affect the validated state of the equipment;
  • Represent Validation and Quality during customer audits or regulatory inspections;
  • Support of Operational Excellence activities for the Site;
  • Demonstrated ability to forecast and manage project work correctly and independently;
  • Review URS’s (User Requirement Specifications) and provide guidance and recommendations on an engineering project;
  • Able to clearly and concisely write protocols, deviations and final reports;
  • Able to correctly assess all change controls;
  • Participate in investigations and process (CIP (Clean in Place), SIP (Steam in Place), Autoclave) failure investigations and CAPAs;
  • Able to resolve discrepancies on the basis of risks involved;
  • Working in safe manner is an expectation and safety training must be up to date;
  • Working on ladders;
  • Demonstrated technical writing skills and thorough understanding of root cause analysis;
  • Specialists may be required to work off-shift or weekends to support manufacturing operations (less than 10% of the time);
  • Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment.

Requirements:

  • Ability to comply with detailed procedures;
  • Some of this work requires entry into a laboratory or cleanroom setting;
  • Substantial Equipment Validation experience;
  • Familiarity with the use of computers Word, Excel, Outlook, Project or equivalents;
  • Bachelor’s degree, preferably in a technical discipline;
  • Contact with internal customers;
  • Ability to read and follow technical instructions in English.