Senior Validation Specialist

Há 7 dias

Região Geográfica Intermediária de São Paulo São Paulo Brazil beBeeValidation Tempo inteiro €80.000 - €92.000
Pharma Validation Engineer

We are seeking a highly skilled Pharma Validation Engineer to join our team. In this role, you will be responsible for designing and executing qualification/validation documentation and cycle development studies in line with the standard approval process.

You will work closely with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.

The successful candidate will have a proven track record in delivering excellence and possess relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.

Key Responsibilities:
  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Engagement with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Resolving technical issues encountered during study execution.
Requirements:
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Knowledge of CTU equipment qualification.
  • Knowledge of thermal mapping equipment.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstrable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
Benefits:
  • Opportunity to work on various aspects of validation, including Sterilisation, Cleaning, Isolator, Controlled Temperature Units (CTU), Filter Validation, and Equipment Periodic Validation.
  • Collaborative working environment with experienced professionals.
  • Professional development opportunities.
What We Offer:
  • A competitive salary and benefits package.
  • A dynamic and supportive work environment.
  • The opportunity to work on challenging projects and develop your skills.

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