Validation Engineer
- Recruiter
- Confidential
- Location
- Mayo
- Salary
- 42300.00 - 63400.00 EUR Annual
- Posted
- 11 Oct 2021
- Closes
- 02 Nov 2021
- Sectors
- Engineering
- Contract Type
- Contract
- Hours
- Full Time
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
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