Collins McNicholas

Validation Engineer

Fixed Term Contract


Role Responsibilities:

  • Creation or update of SOP required for the manufacturing of a product
  • Investigation of the events that may have an impact on product quality
  • Support/generation of the annual product review for products
  • Generation or update of production batch records
  • Support the introduction of new products
  • Assist in the selection of the appropriate technologies to support the product manufacture
  • Develop SOP to support the new equipment
  • Train the operators and other personnel in the new technologies
  • Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, process or technology
  • Ensure activities are executed in line in in-house procedures and in compliance with requirements of cGMP
  • Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc
  • Participation in investigation into failures, out of trends and out of specifications as required ensuring follow up, following anomalies, failures and external compliance, ensuring corrective actions are implemented
  • Be familiar with and apply the procedures, instructions, and rules of the industry and the plant
  • Be responsible for upholding QA rules
    • Ensure that SOP’s are applied
    • Record training for procedures
    • Notify QA about any deviation
    • Carry out corrective actions

Skills, Experience and Qualifications:


  • Third level technical qualification to degree level desirable
  • Two or more years’ experience within a GMP manufacturing environment i.e. Pharmaceutical/Chemical/Food
  • Ability to manager both projects and own routine activities
  • Provide the necessary guidance and leadership on technical projects where required
  • Good people management skills
  • Organisational and administration skills
  • Knowledge of GMP

For a confidential discussion and more information on the role, please contact Phil Burchell on 021-4911064 or email

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