Validation Engineer
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Mayo |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2204 |
| Job Views | 329 |
- Description
- Are you an experienced Validation Engineer, looking for a role in the West of Ireland? If the answer is yes, Team Horizon currently have an opening for a Validation Engineer at our client’s manufacturing site in Mayo. This is a 12-month contract initially. The Validation department is responsible for the qualification / validation of all cGMP equipment, systems and processes utilized for routine operation on site as well as the revalidation of critical systems & processes.
Why you should apply:
You’re passionate about your profession and strive for excellence in everything you do.
You’re ambitious and thrive in working environments where high standards and patient safety are key.
You bring new ideas to the table, are well versed in industry best practice and innovative talent solutions, and you will be integral to the continuous growth of the organization.
You want to work in a culture of innovation, inclusion and development, and you bring out the best in people.
What you will be doing:
Responsible for the qualification of equipment systems and processes as per the site master plan
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.
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 guidance 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.
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 – example Equipment Validation, Cleaning Validations, CSV, Aseptic (Sterilisation Validation), Process Validation, Facility Validation, Automation etc.
