Validation Engineer

Morgan McKinley
Employment Type
€35.00 - €60.00 per hour
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Job Description

Great opportunity to join the well established Pharmaceutical  company on a 12 month contract basis as a Validation Engineer

Validation Engineer – Pharmaceutical – Dublin 

To be successful in this role you will have a degree or qualification in an engineering, science or quality related discipline with minimum 3 years working in a medical device manufacturing industry. An in-depth knowledge of validation and change control management in a medical device environment is essential.

Main Responsibilities :

  • Process validation needs for new manufacturing processes, equipment introductions, and process adjustments are expertly handled
  • Follow established standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requirements while undertaking process validation (OQ & PQ, IQ ).
  • To characterize processes and support process validation activities, use six sigma statistical analysis and experimental design tools.
  • Complete all validation documents by writing, executing, and reviewing them.
  • Coordinates and implements validation change control, as well as procedure and report preparation.
  • Works in cross-functional project teams with Development, Manufacturing, Engineering, Quality, and other departments.
  • Prepares validation testing summaries for regulatory filings as needed, and provides validations to regulatory authorities.

Qualifications :

  • Degree in Engineering / Science discipline, with 3+ years relevant experience.
  • Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
  • Proficient technical report writing skills.
  • Experience in regulated industry, FDA, ISO, etc.
  • Proficient in current Good Manufacturing, Engineering, Practices etc (GxP).