Our client, a leading healthcare company based in Clare, currently has an opportunity for a Validation Engineer to join their team. This is a 6-month contract position offering an excellent salary and benefits package.
Develop and maintain validation plan in line with global and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities in relation to the Iris transfer project
Plan and develop Iris transfer site validation project schedule with cross-functional teams and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritization of validation activities in line with the IRIS transfer project schedules and plant priorities.
Liaise with current manufacturing site in Germany to ensure effective transfer of knowledge to Ireland.
Lead, integrate & manage Iris transfer validation tasks and develop strategies on the Iris transfer validation project with multifunctional project teams ensuring the Iris transfer project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.
Understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines.
Prepare, review and execute Iris transfer project validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards
Participate in the preparation of user requirement specifications for the Iris transfer project to ensure that they comply with Validation and GMP requirements as required
Execute/co-ordinate re-validation/qualification activities as required
Review/Approve change controls and assess impact of changes that affect Iris products.
Provide technical expertise during investigations, gap analysis, risk assessment and change control process.
Education & Experience:
Bachelor’s degree in field with 5+ years exp. OR
Master’s degree in field with 3+ years exp. OR
Desirable to have previous experience in site transfers and Process/Equipment validations.
Ability to travel approximately 25% per month to Germany may be required
Excellent planning and organisational skills
For more information on this position please call Rachael O Rourke on 061336136 or apply online and a member of the Harmonics team will be in touch