Senior Validation Engineer
Lotusworks
Limerick
About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Limerick is the capital of Ireland’s Mid-West region and is noted for its shopping, its dining and entertainment, its historical significance. Limerick has something to offer everybody thanks to its many cultural, historical, architectural, sporting, shopping and business activities. Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose. Working with the LotusWorks team as a Senior Validation Engineer, you will provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Validation Policies and Procedures are addressed. Responsibilities. Managing Complexity/Technical Accountability. Serves as technical expert for the Validation process and responsibilities to ensure compliance. Continuous Learning/Managing Risk. Resolves & manages technical operational problems in area of expertise. Suggest and sometimes may implement innovation and continuous improvement within the Validation process. Implements initiatives in the Validation Process that will deliver customer value at lowest cost. Facilitates successful team behaviour within Quality Systems and across functional areas. Manages relationships externally and internally. Builds cross functional and cross-departmental support, fostering overall effectiveness. Fosters harmony within Quality Systems. Influences and persuades so as to bring about technical and process improvements. Ensure accuracy and maintenance of the Validation Master List. Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise. Ensure all validation activities and documents are authorised and appropriate compliance approval is gained. Ensure that all validation activities are carried out and reported in a timely manner. Ensure compliance through assisting in audits. Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Policies and Procedures. Requirements. Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base. Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations. Knowledge of bespoke validation. Process knowledge and documentation. In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry. High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. Working experience of validation computer systems for use in a FDA regulated environment. Must be able to lead and give direction to Validation Projects and Teams and be an active team member in Validation activities. Benefits. LiFe Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email jobs@lotusworks.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 27 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
2401 days ago