Validation Technician

Validation Technician
On-Site – Ceredigion
Monday – Friday 9am – 5pm

This role requires the delivery of validation activities to support manufacturing at the Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers, and regulatory authorities. A member of the validation team who provides direct support to the efficient delivery of the Site Validation Master Plan (SVMP) Schedule. 
Principle Responsibilities

  1. Responsible for the completion of assigned validation activities on time in accordance with the SVMP schedule.
  2. Generation of related project documentation and protocols for installation, operation and performance qualifications, Validation plans and reports
  3. Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
  4. To follow all Standard Operating Procedures (SOP’s), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.
  5. To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
  6. To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
  7. Liaise with external contractors to arrange the completion of PPM activities, and the subsequent administration of PPM to closure.
  8. Supports the administration requirements for Validation documentation during Regulatory Inspections.
  9. Supports internal audits where required, taking responsibility for the closure of assigned actions in a timely manner.
  10. Continuously look to support continuous validation improvement activities.
  11. Support other departmental activities as requested by department management or designate.
  12. Ensure that all interactions and engagements are carried out in accordance with Company DNA and that all work is accomplished with quality and in accordance with the Company values.
  13. Carry out other reasonable tasks as required by the Line Manager.

Education and Experience

Skills and Attributes

Applications are encouraged from all sections of the community.