Validation Engineer

42300.00 - 63400.00 EUR Annual
11 Oct 2021
02 Nov 2021
Contract Type
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

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