Lead Validation Professional -Biotech

This global Biotech leader employs over 20,000 staff worldwide. They are committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, this business has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Due to the continued success across the business, the External Quality group seek an experienced Validation professional to join their team on a remote basis (Home based).

The Role:

Part of the External Quality group and reporting into the Director for External Quality Europe, the Principle Validation Engineer will carry out the following responsibilities:

  • Act as an integral Validation member of the External Quality group and work cross-functionally with contract manufacturing sites
  • Carry out Team filing validation content and strategies
  • Handle questions from regulatory bodies
  • Defend Validation strategies
  • Act as Validation document author/ approver
  • Manage aseptic processing systems oversight
  • Present on topics during inspection demonstrating appropriate behaviours and knowledge
  • Perform Validation change control assessments
  • Review / approve Master Batch Records
  • Write / review RTQs
  • Author applicable MA filing section

The Person:

You must possess the minimum to be considered:

  • Education: BSc, MSc in life science or related
  • 10 + years’ industry experience (of which the most recent years have been spent in the Biotech sector)
  • Demonstrated Validation knowledge and experience
  • Will consider a candidate with previous experience in technical transfers or Quality Assurance who has more recently moved into Process Validation
  • Hold an EU passport / Eligible to live and work in Ireland

The Benefits

  • Competitive basic salary
  • Generous bonus
  • Stock options (Both LTI’s and Sign on Stock)
  • Full family healthcare
  • Pension (Defined contribution)
  • Flexitime
  • Minimal travel for an External / Virtual role
  • Remote work is a requirement – this person will be 100% home based

To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 1 6321827 for a confidential discussion.

Salary: On Application Location: Dublin North