Our client based in Westport are looking to hire a Validation Engineer on an initial 12 month contract for an exciting new project.
- 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).
- 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.
091 706 717