Software Validation Engineer
Lotusworks
Galway
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. Galway is a City and County which caters for everyone. Even though Galway City is one of the fastest growing cities it still retains that friendly feeling! With Culture, Dining, Socialising, Sport, Leisure and a state of the art University and College, there is a fantastic lifestyle on offer if you are relocating. If you already live in Galway, well then lucky you! 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. Ensures that best software validation practices are employed by all departments so that computerised systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements. Your Responsibilities: Ensures that software validation is carried out in compliance with site/corporate policies and SOPs. Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems. Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols. Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team. Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes. Provides software validation/compliance/part 11 training and collaboration in accordance with policies and SOPs. Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence. Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, for resolving quality issues and for Continuous Improvement. Requirements: A degree qualification in science or engineering with a minimum of 5 years’ experience of validation activity in a project environment. Software/Validation experience. Excellent problem-solving and analytical skills. Experience in all or some of the following: Vision Development, Motion Control, Web application development, Machine/hardware integration, Software change management. Excellent communication / interpersonal skills. Strong Attention to detail. 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 Email jobs@lotusworks.com and we will be happy to help! Empowering talent we care about for over 27 years. LotusWorks is an equal opportunity employer. This job originally appeared on RecruitIreland.com.
2793 days ago