Computer System Validation Engineer

Paciv

Kildare

Position: Computer System Validation Engineer 5+ Years exp with Valid EU Work Permit or Irish Residency. PACIV, a global leader in industrial automation solutions with offices in Ireland, the US and Puerto Rico, and serving the Life Sciences, F&B and Utilities industries, is looking for a regular employment-based Computer System Validation Engineer with 5+years’ experience for its Client site in the Kildare/Dublin area in Ireland. Job Description: The Computer System Validation Engineer will primarily be responsible for automation data integrity and cyber security projects.  This is a GMP facility, and all engineering activities will be performed in a manner consistent with project computer system validation and documentation practices.   Position Responsibilities/Essential Functions.   Education:  Degree in Chemical Engineering, Applied Physics & Instrumentation, Electrical or Electronic Engineering, ICT or qualifications in other relevant engineering discipline with appropriate experience.   Role Requirements. Strong planning, leadership, influencing and project management skills. Minimum 5+ years’ Computer Systems Validation experience gained working in a life science GMP environment - Pharma or Biotech engineering, operations, or manufacturing. 5+ years’ experience of automation data integrity projects. 2+ years cyber security project experience. 5+ years’ experience in managing documentation of large automation projects or equivalent. Exposure to computer system validation principles and practices. Proficient in the use of MS Office products (Word, Excel. Working knowledge of MS Project or equivalent planning software  Demonstrated teamwork abilities  Knowledge of GMPs and regulatory requirements related to good documentation practices. Experience of electronic document management systems. Good written and verbal communication skills for both technical and non-technical audiences. The candidate should have a strong attention to detail and have excellent organisational skills. Must have a Valid EU Work Permit or Irish Residency.   .   Desired Hard Skill Sets: Significant computer system validation experience. Significant automation data integrity experience. Significant data mapping experience. Significant cyber security experience. Experience of engineering computer networks, cloud infrastructure and enterprise networks. Development and execution of CSV deliverables for system-development life cycle of industrial automated systems. Proficient knowledge of CSV system life cycle concepts and EMA and FDA regulatory requirements, including FDA cGMPs, 21 CFR Part 11 and GAMP5. Experience with development of Risk Assessments, URS, FRS, DDS, DQ, Validation and Test Planning, Development and Execution Commissioning and Qualification protocols.   Desired Soft Skills: Strong people, influencing and leadership skills. Strong planning and project management skills. Automation systems background  Strong analytical and problem-solving skills. Deals well with ambiguity, uncertainty and pressure. Works well with others, within a team and takes accountability. Result driven and self-motivated. Strong interpersonal and communication skills (verbal and presentation. Organised, with strong computer literacy such as MS Project, Excel, etc. Fully fluent in English.   Other Requirements. Location: Kildare/Dublin region, Ireland. Must have a Valid EU Work Permit or Irish Residency.  No agencies at this time please .

1244 days ago