CSV Engineer/ IS Compliance Job in Dublin, Dublin Ireland
We are currently looking to recruit an CSV Engineer for an IS Compliance Role within our consultancy team, on a project basis initially, based on site at one of our client sites in Dublin.
CSV Engineer / IS Compliance
This role will report into the IS Compliance Manager and will have a lot of face-to-face interaction with IS group and other departments.
RESPONSIBILITIES:
- Carry out audits of IS and Automation systems, Lab IS systems
- follow-up on remediation actions, ensure timely closure - security audits, DRP audits.
- Ensure IS training is up to date, monitor training metrics and follow-up
with individuals as needed to ensure compliance - Development of IS SOP's e.g. periodic review, change management setup, a periodic review schedule and criteria for all IS systems
- Check all SLA's are in place and software licenses are up to date
- Work on Disaster Recovery Procedures for IS systems.
- Setup schedules for Data Integrity Assessments, ensure they are carried
out. - Check that all Part 11 assessments are available; take necessary action if
they are not. - Ensure the IS group is audit-ready at all times.
- Manage the system inventory document to ensure it accurately reflects all
IS systems on site, the system owners and business owners. - Carry out internal audits of the IS department .Keep IS staff up to date
with new training requirements, improve their understanding of IS compliance - Take a project management oriented approach to tasks, put a plan in
place, follow-up on the plan and close items out.
REQUIREMENTS:
- Pro-Active
- Self Starter
- Good customer facing skills
- Project Management
- Minimum of three years computer validation experience in a pharmaceutical or biotech facility
- Knowledge of Audit compliance requirements, preferably within a pharmaceutical manufacturing environment
ABOUT US:
Enterprise System Partners (ESP) is a project engineering company, headquartered in Ireland, with a proven track record in delivery of IT Manufacturing Solutions to the life sciences industry. We provide systems support for the planning, vendor selection, design and implementation of systems for the entire manufacturing landscape from the automation layer (DCS, SCADA) right up to the ERP layer (e.g. SAP, JD Edwards) with particular expertise in manufacturing and laboratory systems.
Our unique strength is our people collectively understand the entire system landscape within the manufacturing environment. This includes expertise in Manufacturing Execution Systems (MES), (including document management systems, maintenance/calibration systems, CAPA systems, Material Tracking Systems, Electronic Batch Records and WD) and integration of these systems throughout the entire systems landscape. We have offices in Cork, Dublin and Massachusetts, US, with our team based on pharmaceutical plants in Ireland, Europe and North America.
We are rapidly growing company that needs highly motivated people to help drive it forward.
We consider applicants on a permanent or contract basis and offer genuine career prospects and training opportunities.
