Validation Technician

Thermo Fisher Scientific East Grinstead, England

About the Job

The Validation Technician will have day to day responsibility for executing and documenting validation activities including but not limited validation and impact risk assessments, URS, FAT, SAT, IQ, OQ, PQ and VSR.

You will be part of a growing Validation Team within the Quality Function and be expected to work alongside colleagues in Quality, Manufacturing and Engineering at East Grinstead and other sites from time to time.

Responsibilities:

  • Assist in the preparation of validation protocol (equipment, cleaning, computerized system and processes) to include, but no limited URS, FAT, SAT, IQ, OQ, PQ and VSR.
  • Execution of validation protocol (equipment, cleaning, computerized system and processes) to include, but no limited URS, FAT, SAT, IQ, OQ, PQ and VSR.
  • Assisting system owners with impact risk assessments and identifying qualification/validation requirements.
  • Carrying out all validation activities on equipment before handover/return to system owner and updating all relevant record schedules.
  • Assist in arranging specialist services to qualify specialist equipment.
  • Assist the Validation Specialist supervising technicians, fitters and contractors as required when external support is utilized for qualification activities.
  • Maintaining qualification related records, procedures, documents and drawings.
  • Ensuring compliance with safety, health and environment (SHE) legislation.

Minimum Qualifications:

  • Validation, QA or engineering experience within a GMP environment
  • Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, consumer health care, microbiology or related industry.
  • Knowledge of validation requirements for international markets including (but not limited to) FDA and EMA.
  • Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines.
  • Proven problem solving skills, diagnosing faults and resolving qualification issues to get the best outcome for the stakeholders and business.
  • Excellent planning and time management with the ability to adapt to rapid changes in project priorities and meeting aggressive timelines