Commissioning & Qualification Engineer
Lotusworks
Cork
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. Based at Ireland’s southwest coast, Cork is home to a large university with pharmaceutical and medical device hubs across the county. From sports, culture and activities Cork has so much to offer! 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 Commissioning & Qualification Engineer, you will be responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. Requirements. Degree or 3rd level qualification (Science, Engineering, Process. Have at least 1-2 years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical/Validation role in a manufacturing environment. Have Troubleshooting and analytical mind-set with an understanding of regulatory and validation requirements. Working knowledge of equipment and systems specifically Autoclave or cleaning validation an advantage. Ability to interact with multiple stakeholders. Excellent verbal, written, and interpersonal communication skills are required. Responsibilities: This includes preparing protocols independently, analysing test results, and preparing technical reports. Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing. Author/approve Change controls as appropriate. Represents the department on cross-functional project teams. Understanding of the concepts of BioTech manufacturing would be desirable. As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections. 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 07191-69783 or Emailjobs@lotusworks.comand 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.
2438 days ago