IT LABORATORY CSV ENGINEER required by CareerWise Recruitment on a Permanent basis for our Biologics client in Limerick.
The IT LABORATORY CSV ENGINEER will have knowledge of IT infrastructure platforms and ISA S95 architecture along with strong working knowledge of quality control laboratory IT systems (i.e. Empower, Lab Vantage, etc.) and be familiar with Agile methodologies.
THE ROLE:
- Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance)
- Develop in-depth knowledge of IT functionality of relevant lab equipment to aid in installation, upgrade and maintenance activities
- Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing , Data Migration, SOPs, Change controls and Deviation Investigations.
- Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.
- Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc).
- Ensure new instrument installations and software upgrades are delivered in time to meet business needs.
- Lead computerised instrument upgrades and improvement projects, promoting and providing solutions to business problems.
- Resolve system problems using data analysis and problem solving skills.
- Participate in and support audit activities
- Represent the site and share knowledge at corporate forums
- Develop a 'network' of corporate contacts and resources
- Participate, contribute and report at team meetings
REQUIREMENTS:
- Bachelor’s Degree (Level 8) in Information Technology, Computer Science, Engineering or related field
- Minimum of 5+ years of experience in a biotech or pharmaceutical setting
- Extensive knowledge and experience in development and execution of Computer system validations, in particular the laboratory systems area.
- Experience in administration of computerised lab equipment
- Demonstrated troubleshooting ability, understanding of lab equipment software.
- Extensive understanding of regulatory requirements associated with CSV, including ER/ES(21CFR Part 11), security and data integrity.
- Demonstrated initiative to build relationships, learn new business processes and identify opportunities
- Strong leadership and influencing skills and the ability to work in cross-functional team environments, as well as independently.
- Strong analytical and problem-solving skills are required
- Strong written and verbal communication skills are required.
Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.