Validation Engineer

 

Job Title: Validation Engineer

Job ID: VAL-TECH01

Department: Technical

Job Description:

Reporting to the Technical Director, the Validation Engineers shall write and execute validation protocols, provide support and troubleshooting to clients within the Pharmaceutical, Biologistics, Chemical and Medical Device industries. Validation engineers evaluate and calibrate the equipment and procedures used in development and production of a variety of products. They ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.

Note: VQS Ltd operate a Clean Desk Policy to eliminate the possibility of potentially sensitive data being compromised

Duties:

The Validation Engineer duties include (but are not limited to) the following:

  • Writing and execution of qualification testing protocols
  • Advice on compliance issues to Engineering and QA
  • Generation of validation documentation compliant with the regulatory requirements of the governing body relevant to the project (Typically the MHRA/ FDA)
  • Presentation of validation documentation to clients/auditors.
  • Writing and approval of validation life-cycle documents (VP/URS/RTM/DQ/IQ/OQ/PQ).
  • Writing and approval of change control documentation for equipment and manufacturing processes.
  • Advice on continuous improvement exercises for process manufacturing, and the impact of change on process validation status.
  • Execution of thermal mapping and creation of validation reports.
  • Analysing and interpreting test data
  • Creating databases to track validation activities
  • Interpreting customer requirements
  • Developing validation schedules
  • Preventative maintenance, maintenance of testing equipment and overseeing the inventory of validation supplies.

Essential Skills

  • Ability to evaluate Information to determine compliance with standards – using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
  • Good communication skills; able to liaise confidently with clients, colleagues – Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Analysing Data or Information – Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
  • Identifying Objects, Actions, and Events – Identifying information by categorising, estimating, recognising differences or similarities, and detecting changes in circumstances or events.
  • Competent user of Microsoft Word, Excel, Visio & Exchange.

 

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