Validation Engineer
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| Job Type | Contractor |
| Area | Mayo, Ireland |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3102 |
| Job Views | 439 |
- Description
- Team Horizon is seeking a Validation Engineer on a contract basis for a manufacturing facility in Co. Mayo.
Why you should apply:
Excellent opportunity to join an experienced & diverse Validation team with the chance to work on varied & interesting projects.
What you will be doing:
Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner.
Ensure all validation requirements are met for any new process, equipment or change to existing processes or equipment.
Actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations.
Ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized and filed in a timely and organized fashion and 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 guidances 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).
What you need to apply:
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 – e.g Equipment Validation, Aseptics (Sterilisation Validation), Vial Processing Line (Vial Washers, Deprogenation, Filling, Lyophilisation, Isolator Technology), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation etc.
