MES VALIDATION ENGINEER
We are a rapidly growing company that needs highly motivated people to help drive it forward. We are currently looking to recruit an experienced MES CSV Engineer to join our company.
This is a role for an experienced IT validation specialist to oversee the validation of electronic batch records as part of the site MES implementation project team. You will co-ordinate and execute validation deliverables in accordance with current Good Manufacturing Practices, regulatory requirements and company procedures.
Within this role you will:
Ensure software validation is carried out in compliance with site/corporate policies and SOPs.
Ensure that best software validation practices are employed by the validation team so that electronic batch records are developed, validated and documented in a consistent manner which provides assurance that they conform to both established GMP and technical requirements.
Assist/advise on the creation of URS, Design specifications, OQ and PQ protocols etc. where required.
Generate SOP to document validation strategy for electronic batch records.
Co-ordinate and monitor the validation phase and provide project manager with weekly progress reports.
Assist/advise IT/Automation leads with the validation of interfaces from the MES system to Automation control systems.
Previous experience in a Computer Systems Validation role (ideally being familiar with Pas|X) in a regulated Pharmaceutical/BioPharmaceutical industry
Thorough working knowledge of relevant regulations, e.g. FDA 21 CFR Part 11
Proven systems validation success.
Hands on experience in implementing a MES Solution an advantage
Basic understanding of interfacing with control systems is highly desirable.
Experience of developing and delivering training.
Project management and problem solving skills
Excellent communication skills, both written and verbal.
Enterprise System Partners (ESP) Ltd is a highly successful project engineering company, which provides systems support to the life science industry in Ireland for the planning, vendor selection, design and implementation of systems 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 W&D) and integration of these systems throughout the entire systems landscape. We have offices in Cork and Dublin, with our team based on pharmaceutical plants around the country.
Follow us on Twitter – www.twitter.com/ESPNewsandJobs