Validation Engineer

3 weeks ago

Dartford, United Kingdom Cranleigh STEM, Sustainability & SHEQ Recruitment Full time

A Coatings Company is currently seeking an Equipment Validation Engineer/Officer to join the team. This pivotal role involves spearheading the creation, development, and support of validation processes, as well as implementing ongoing optimization and harmonization strategies for production-scale manufacturing equipment. Successful candidates will bring a proven track record in production-scale validation, with specific experience in powder blending or handling active ingredients considered advantageous. This is a hybrid opportunity.


Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

MAIN RESPONSIBILITIES

  • Assist in creating, developing and providing support for validation and ongoing optimisation and harmonisation strategies for production scale product manufacturing-related equipment.
  • Assist in creating process validation and equipment qualification protocols and reports (which may include FAT).
  • Assist with review of qualification/validation protocols including support to global manufacturing sites.
  • Assist to maintain the status of global master specifications for manufacturing equipment, and the global master manufacturing documentation for excipient blends.
  • Prepare validation, stability and qualification protocols and subsequent reports.
  • Assist with the evaluation & validation of raw materials from both current and new suppliers.
  • Assist in trials carried out with suppliers and / or customers.
  • Formally stability test products containing these raw materials.

EXPERIENCE REQUIRED

Essential

  • Degree (or equivalent) in science or engineering-related qualification
  • Proven experience of Validation of Equipment in a manufacturing environment
  • Proven validation experience within a highly regulated manufacturing environment (Medical Devices, Pharmaceuticals, Food etc.)
  • Knowledge & experience of excipient blend products and raw materials
  • Report Writing

Desirable

  • Experience of process development, optimization, scale-up & validation studies
  • Experience of equipment evaluation & qualification studies
  • Proven knowledge and experience of Change Control and Risk Management processes.
  • Knowledge and experience of EXCiPACT and/or ISO 9001 requirements is highly advantageous.
  • ISO / GMP / GLP /COSHH / H&S awareness

This is a hybrid opportunity with the added benefit of a flexi-time scheme.

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