Validation Engineer

  • Type: Contract
  • Location: Clare
  • Salary: Negotiable
  • Job Ref: VEE040119
  • Date Posted January 4, 2019

Our client, a leading healthcare company based in Clare, currently has an opportunity for a number of Validation Engineers to join their team. These are 10-month contract positions offering an excellent salary and benefits package.

Main Responsibilities:

  • Write, review, approve and execute Validation Protocols for the Blood Virus Project (for Equipment, Utilities, Processes, Cleaning, Test Methods, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
  • Write, review and approve Validation Reports ensuring compliance to all relevant global and local quality and validation procedures/standards
  • Participate in the preparation of User Requirement Specifications to ensure that they comply with Validation and GMP requirements as required
  • Execute/Co-ordinate Re-Validation activities as required
  • Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements
  • Represent Validation at both internal and external audits.
  • Participate in, and Support the operation of Validation Visual Daily Management
  • Support DBS improvement initiatives in Validation Team including PSP and Kaisen events
  • Co-ordinate/Supervise Contractor Qualification activities
  • Administer Validation files and ensure that Validation Logging System is maintained, tracking Validations and Validation Files and ensuring full record accessibility.

Education/ Experience

  • Third level degree in science or engineering in addition to 3 years relevant experience in a GMP/FDA/IMB regulated environment.
  • Experience of formal regulatory audits (e.g. FDA/IMB) and good working knowledge of statistics, desirable.

For more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch

More Details

For more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch

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