Validation Specialist

Recruiter
THERMOFISHER
Location
Caputh
Posted
14 Feb 2019
Closes
28 Feb 2019
Sector
Engineering
Contract Type
Permanent
Hours
Full Time

This exciting new role has arisen to join our Microbiology Division based in Perth UK.

What will you do?

  • Maintain the validation schedule and keep all equipment and processes in a qualified state to support GMP requirements
  • Preparation and execution of validation protocols (equipment, computerised systems and processes)
  • Assisting system owners with impact assessments and identifying qualification/validation requirements
  • Carrying out validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
  • Arranging specialist services to qualify specialist equipment
  • Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities
  • You may be called upon to represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems
  • Creating/maintaining qualification related records, procedures, documents and drawings
  • Ensuring compliance with safety, health and environmental (SHE) legislation
  • Engaging with project teams to help with selection, installation and commissioning of new equipment
  • Any other task required from time to time to assist the efficient running of the Company’s business.

Who are we looking for:

  • Validation experience within a GMP environment would be beneficial
  • Demonstrable validation experience in a medical device (ISO13485), biopharmaceutical, microbiology, consumer healthcare or related industry.
  • Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
  • Working knowledge of Computerised System Validation to include Building Management Systems, PLC, automated manufacturing and spreadsheets.
  • Working knowledge of commissioning and equipment qualification to include autoclaves, controlled temperature units and automated production lines
  • Experience of manual and automated cleaning method validation
  • Proven problem solving skills/diagnosing faults/resolving qualification issues
  • Excellent planning and time management ability
  • The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
  • The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.
  • Demonstrated effective interpersonal skills with an ability to interface well at all levels. Good oral and written communication skills
  • Mechanical/Chemical Engineering Degree

What's in it for you?

  • Contributory pension scheme
  • Private medical insurance
  • Flexible benefits scheme
  • Free onsite car parking


About us:

As the world leader in serving science, our work is more than something that fills our days. When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Each one of our 70,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best - professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer. Apply today!

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