Validation Engineer

Vacancy Validation Engineer Location Wicklow, Ireland Hours Full-time

Validation Engineer

Intent

Does a career in Computer Systems Validation and helping our BioPharma customers get new therapeutics to market faster, excite you? We are looking for an experienced Validation Engineer with a background in QC Laboratories, GxP environments and instrument integration for a full time onsite position on the Westmeath / Offaly border.

Our customer is accelerating their Scientific Informatics and Digital Transformation to improve batch release by incorporating new equipment into their Labs. Consequently, we are rapidly growing and looking to expand our technical team. This is an exciting opportunity to join our Validation Team in Ireland and help our customers deploy and support cutting-edge scientific technologies.

With good knowledge of Computer Validation, System Backup and Recovery, Data Archiving, Business Continuity (Disaster Recovery), System Access & Security, Training and Training Documentation, Use of Electronic Signatures, Document Control, System Operation and System Maintenance, you will be responsible for leading the deployment of validated systems to build the modern R&D Informatics landscape. You will own and lead validation projects for your customers and ensure Zifo solutions meet GxP and other regulatory requirements. You will design and plan validation projects and establish best practices.

This role is based in Ireland therefore there is a need for strong English language proficiency in a business context.

Core Responsibilities:

Achieving the objectives and procedures of Computer Systems Validation (CSV) specifically 21 CFR part 11 and EU Annex 11, PIC/S, MHRA Data Integrity, Japanese ERES and GDPR Consulting and input to guide and shape validation strategy using your knowledge of cGMP, GxP, GLP, GDP, and industry health and safety regulations Requirements analysis, definition, and implementation of software validation projects. Create validation roadmaps and relevant validation project program artefacts to manage stakeholders and support the achievement of the clients’ quality and compliance objectives. Develop and write validation master plans and validation procedures (SOPs) according to regulatory requirements. Generation and execution of validation protocols and reports (including URS, IQ, OQ, PQ, QAP, etc.). Performs qualification and validation of computerised systems, equipment, facilities, services, and processes in line with client procedures and industry standards. Develop and execute Commissioning & Qualification lifecycle protocols per the specific project requirements. Identify and suggest the system administration configuration based on Data Integrity and customer needs Document procedures and flow maps and ensures adherence to client’s corporate policies and procedures Identify the gaps in the system, propose and develop mitigation action Supporting Quality Management processes, Periodic Review of GxP Systems, Change Control, Incident / Problem Management, CAPA. Ensure audit readiness and provide pre-audit preparation and support Nurture long-term relationships and partner with customers, vendors, partners and third parties. Guidance and oversight for validation teams; acting as the voice of the customer and mentor for other validation team members as part of a global team in an international environment. Ability to work effectively in a regulated and/or ISO-compliant environment.

Ideally, you will have the following skills: 

Awareness of ITIL, SDLC processes and/or Computer System Validation methods, such as GAMP5. Strong collaboration skills with the ability to manage several tasks simultaneously and a self-starting, proactive and flexible approach. An analytical thinker with a structured problem-solving and flexible approach. Proven experience validating solutions On-Prem or in the Cloud especially Instrument/equipment software Strong understanding of established and evolving industry standards and best practices driving computer systems validation.

Nice to have: 

Experience with Scientific Informatics solutions A Background in biochemistry, bioinformatics, pharmacy or chemistry with relevant practical experience and familiarity with laboratory processes, Scientific Informatics or Manufacturing. Experience in Life Sciences Industry. Experience supporting pre-audit, audit, audit findings and remediation planning. Proven experience with project delivery processes and methodologies – Waterfall, Agile, Safe, CI/CD, DevOps, ITIL and associated tools

What is Zifo:

Zifo RnD Solutions is a fast-growing global organization with a presence in US, UK, Germany, France, Japan, China, Singapore, Switzerland, Spain, Ireland, Canada, and India. Zifo helps organizations strategize, design, implement and support their systems in the areas of Laboratory Informatics, Scientific Data Management, Clinical Biometrics, Genome Informatics and Compliance Solutions.  If you are attracted by the idea of joining a team where the employee is integral to the success of the company, where trust, empowerment and self-development are more than just words…. then Zifo could be the Company for you. Here at Zifo, these values are the backbone of our culture.

We offer an attractive salary in addition to a competitive benefits package and look forward to receiving your application. Send your resume to and visit our website at www.zifornd.com

Closing Date Tuesday 31 October 2023

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