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Validation Engineer, Galway



Galway, Ireland 

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Job Description:

The Opportunity
Team Horizon is seeking a Validation Engineer to join a globally successful generics and speciality pharmaceutical company on a permanent basis. The ideal candidate will have 2-4 years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment
The Role
  • Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
  • Validation/Qualification projects will be across a range of production areas which may include, Equipment Qualification (Lyophilisers, Autoclaves, Filling Lines etc), Product Processes, Cleaning, Computerised Systems, Utilities and associated Capital projects.
  • Act as a subject matter expert in process validation which will be performed against Corporate SOP/HPRA /FDA/EMEA requirements.
  • Generation, execution and close out of validation projects relating to existing products and new product introductions.
  • Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
  • Statistical analysis of data to determine process capability.
  • Execution and documenting of process risk assessment / failure mode and effects analysis.
  • Track and resolve exceptions during qualification activities.
  • Represent validation at internal and external audit.
The Person
  • Minimum of a Diploma in a Science/ Engineering or related discipline and 2-4 years’ experience in a Technical/QA/ Validation Role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes.
  • Experience in statistical analysis techniques and process validation will be considered a distinct advantage.
  • Must process knowledge of Pharmaceutical Manufacturing Programs
  • Must possess strong project management and organizational skills. Self-motivation and drive.
  • Excellent interpersonal, communication (written & oral) & technical report writing skills.
  • Must be flexible and able to manage multiple priorities simultaneously.
  • Must be an active learner and have a positive leadership attitude.
  • Proficiency in speaking, comprehending, reading and writing English is required.

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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