*Free training & placement program.
Validation is the documented process of demonstrating that a system or process meets a defined set of requirements. There are a common set of validation documents used to provide this evidence. A validation project usually follows this process:
Validation Planning – The decision is made to validate the system. A project lead is identified, and validation resources are gathered.
Requirement Gathering – System Requirements are identified. Requirements are documented in the appropriate specifications. Specification documents are reviewed and approved.
System Testing – Testing Protocols are written, reviewed, and approved. The protocol is executed to document that the system meets all requirements.
System Release – The Summary Report is written, and system is released to the end-users for use.
Change Control – If changes need to be made after validation is complete, Change Control ensures that the system changes do not affect the system in unexpected ways.
Responsibilities and Duties
- Author, customize, and execute commissioning and qualification protocols for environmental chambers.
- Must have previous experience temperature mapping of refrigerators, freezers, incubators, warm and cold rooms
- Support completion of System Impact Assessments and Critical Assessments.
- Responsible for the generation and maintenance of validation procedures, validation master plans and validation reports.
- Familiarity with assisting with gap protocols and re qualification of equipment.
- Must be able to set up probe not just execute.
Required Experience, Skills and Qualifications
- Bachelor’s degree in Engineering or Science or related field.
- Must have demonstrated understanding of cGMP.
- Experience with Kaye Validators or e Labs is strongly preferred.
- Strong understanding of compliance and regulations.
- Excellent written and verbal communication skills.