Validation Specialist Job Description Template
Our company is looking for a Validation Specialist to join our team.
- 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.
- 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.