Validation Engineer III

  • Location

  • Salary

  • Job Type

  • Functions

    Quality Assurance

Validation Engineer (Senior) – 12 month & 6 month contracts

Onsite position (Western Ireland) – Potential to WFH on ad-hoc basis at discretion of manager.

Joining team of approx. 6, reporting to Validation Team Leader.


  • Coordinate the development & maintenance of validation programs in compliance with applicable regulatory and company requirements.
  • Help direct, implement and actively participate in the execution of the site Validation Program.


  • Ensure computerized systems are all qualified in compliance with Data Integrity policies and regulatory requirements.
  • Give direction and participate in the validation of site facilities / equipment / utilities / processes / software in compliance with company, FDA, European cGMP and GAMP standards.
  • Generate & maintain Validation Master Plans.
  • Generate & maintain Project Validation Plans.
  • Ensure all validation plans, protocols and final reports are produced to cGMP standard.
  • Review & approval protocols and final reports.
  • Manage of validation change control process.
  • Adhere to and support EHS & E standards, procedures and policies.

Work environment:

  • Given authority to carry out you duties without close supervision, reporting to the Validation Team Leader.
  • Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.
  • No direct reports, but will provide guidance to cross-functionally on Validation.
  • May provide training and guidance to new department members.
  • Close contact with employees within the plant at all levels.
  • Close contact with internal and external auditors, e.g. FDA, HPRA.
  • May lead and chair Cross Functional Team meetings.
  • Expected to provide functional expertise to support daily operations.
  • Seeks Managers input when making decisions which affect the area.
  • Site SME on validation issues and provides guidance on same.
  • Decision making within confines of agreed responsibility with Team Leader.

Qualifications / Attributes:

  • Degree-level qualification in a relevant engineering/scientific discipline
  • 5-10 years’ experience in a cGMP regulated environment is expected as minimum.
  • Strong understanding of regulatory requirements.
  • High level of attention to detail, to ensure accuracy and compliance with procedures at all times.
  • Strong problem-solving skills and the ability to adapt to new regulatory requirements.
  • Results driven, motivated to meet all targets and metric standards as set by site/department and division leaders.
  • Commitment to quality and maintaining a high standard of work at all times.
  • The highest levels of integrity and a strong work ethic.
  • Excellent communication skills. both written and verbal.


  • The position holds a high level of autonomy and an expectation to work on your own initiative.
  • Procedures, policies and guidelines must be followed to ensure compliance with cGMP and HPRA/FDA regulations.
  • Full responsibility for the co-ordination and closure of projects assigned.
  • This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
  • Requires an ethos of Right First Time at all times.

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