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Validation Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19034

Our client based in Westport are looking to hire a Validation Engineer on an initial 12 month contract for an exciting new project.


Responsibilities:

  • Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner.
  • To ensure all validation requirements are met for any new process, equipment or change to existing processes or equipment.
  • To actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations.
  • To ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized and filed in a timely and organized fashion.
  • To work with the other validation engineers to achieve compliance by coordinating each validation project assigned.
  • Ensure timely review of validation documentation and data generated within the team & ensuring all supporting data and packages are presented in the required format.
  • Keep abreast of current and changing regulatory guidelines for the relevant areas of validation that applies.
  • Provide support for audit preparation, direct audit interaction and involvement in audit responses.
  • Participate in risk assessment process for all business units & participate in design review process for all business units.
  • Support and comply with internal EHS requirements, procedures and policies.
  • Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards.
  • Attend Departmental and OPEX meetings and participation in Quality and Safety Initiatives.
  • Provide support for audit preparation, direct audit interaction and involvement in audit response. 
  • Participation in site internal and external audit program (to include periodic review).

Requirements:

  • Bachelor’s Degree in science based or engineering discipline.
  • Minimum 5 years’ experience in the area of validation / similar role.
  • Ability to articulate clearly when dealing with internal and external bodies.
  • Excellent conflict handling skills.
  • Good written and oral communication skills and ability to communicate to all levels.
  • Excellent problem solving skills, time management & project management skills.
  • Expertise in the relevant subject matter areas – example Equipment Validation, Aseptics (Sterilisation Validation), Vial Processing Line (Vial Washers, Deprogenation, Filling, Lyophilisation, Isolator Technology), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation etc.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717