Validation Engineer

Lotusworks

Dublin

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. Your Job Purpose. Working with the LotusWorks team as a Validation Engineer, you will be responsible for providing process and equipment qualification support. Responsibilities. Ensure all equipment qualified in compliance with industry standards. Ensure all company and site engineering policies and procedures are adhered to. Provide expert review of testing protocols and reports. Lead major equipment related investigations and implement equipment CAPA and performance improvements. Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports to maintain the equipment in a validated state. Provide technical training on process and equipment as required by Operations. Develop and maintain productive links with process equipment & technology supplier and vendors. Support Compliance Inspections and enquiries from Regulatory Agencies. Provide technical expertise during audits and to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies as required. Demonstrated ability to fully realize improvement initiatives. Ensure the highest Quality, Compliance and Safety standards by participating and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Requirements. BSc Degree in Science or Engineering. 5 years’ experience in Equipment, Process Validation Engineering. Pharma background an advantage. 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 2019. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.

2140 days ago