You will join our high-performance team of Technical Engineers and work within an expanding team providing cutting-edge solutions to clients. You will work as part of a team of CSV engineers carrying out validation services across an expanding client base.

Responsibilities

• Provide subject matter expertise in carrying our Computer System Validation on GxP systems to ensure compliance with all applicable regulations including FDA's GLP and GMP/Part 11 and EU Annex 11 and industry guidelines such as ISPE GAMP5, MHRA’s GxP Integrity Guidelines, and GDPR.
• Analyse existing computerised systems for integrity requirements for various automated life science equipment/platform (including laboratory equipment, IT platforms, and manufacturing).
• Conduct CSV Assessments / HealthChecks to assess compliance and report back to stakeholders with findings and suggested solutions
• Ensure completeness and consistency of validation life cycle documentation for computerized systems used to control/monitor and manage data on laboratory and production environments
• Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
• Align with compliance on project management and life cycle documentation deliverables for GxP relevant projects
• Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
• Ensure all project related issues and deviations are documented and approved
• Ensure all project and lifecycle documents incorporate traceability, and these are all retained in the appropriate document repository and approved in accordance to the prescribed SOP

Qualifications

Essential

• Relevant third level qualification or equivalent work experience in chemical, biomedical or biochemical engineering, biological sciences, or related field/experience.

Experience

• Above 2 years’ Computer System Validation experience
• Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements with an emphasis on 21 CFR Part 11, Annex 11, GAMP5, MHRA’s GxP Integrity Guidelines, and GDPR.
• Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting)
• Ability to work as a team player in a consulting environment
• Able to manage direct relation with senior stakeholders and project members as part of the CSV validation process
• Demonstrated knowledge of Software Development Life Cycle (SDLC).
• Possess hands on experience developing of protocols for the Validation of complex computer systems

We are currently only considering candidates who are eligible to work in Ireland for this position

Essential Skills : Quality

Languages Required : English essential

No: of Openings : 1

“We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age”.

• Excellent client-facing skills
• People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
• Team work and emotional intelligence
• Good self-management – continuous performance is both an objective and a mind-set
• Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
• High value on openness and transparency

• Collaborative working environment – we stand shoulder to shoulder with our clients and ours peers through good times and setbacks
• We empower all passionate technology loving professionals by allowing them to expand their skills and take part in inspiring projects
• Expleo Academy - enables you to acquire and develop the right skills by delivering a suite of accredited training courses
• Competitive company benefits such as medical and dental insurance, pension, life assurance, employee wellbeing programme, sports and social events, birthday hampers and much more!
• Always working as one team, our people are not afraid to think big and challenge the status quo