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Title:
Validation Engineer
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Job Type:

Validation Engineer

GerTEK Project Management & Technical Services are an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are accepting applications for our Validation Engineer role based in Sligo.

Job Description 

  • Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes, and software in compliance with client’s policies, FDA, European cGMP and GAMP standards.
  • Develop and execute the qualification for Information Systems and GxP software systems.
  • Ensure up-to-date regulatory requirements for all validated operations
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Lead the definition, design, and execution of computer/automation/ enterprise systems validation and verification activities throughout all phases of the SLC Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Generation of validation protocols and final reports to cGMP standards.
  • Provide input into project phases from design, commissioning, and qualification.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents
  • Management of validation, exception event, and change control processes.
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.

Education & Key Requirements

  • 3 years plus experience writing, reviewing and executing validation documentation – Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM.
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry
  • Project planning experience a distinct advantage
  • Experience with computer controlled equipment automation systems and Human Machine interphases beneficial
  • Strong communication (written and oral), presentation and troubleshooting skill required
  • Effective interpersonal and organizational skills.

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