Global Quality CSV Engineer
Full Time Permanent
Remote
The Role
To contribute to project workstreams across core functions such as sales, commercial operations, procurement, and planning on a global scale. This position offers a CSV engineer the opportunity to play a pivotal role within a major business transformation programme, engaging with projects that impact the organisation worldwide.
MAIN DUTIES & RESPONSIBILITIES
1. Act as an integral project team member for GxP system projects, responsible for supporting CSV implementation plans for the delivery of new applications across Uniphar globally as directed by line management.
2. Advise on the development, implementation, and maintenance of Computer System Validation (CSV) strategies and documentation, ensuring adherence to company procedures and regulatory requirements (e.g., GAMP 5, FDA 21 CFR Part 11, EU Annex 11).
3. Provide pragmatic, expert recommendations for planning and executing validation activities for new and existing computerised systems, including risk assessments, validation planning, protocol development, and reporting.
4. Facilitate collaboration among Quality Assurance, IT, Project management, test teams and project stakeholders by offering guidance to ensure compliance and timely delivery of validation deliverables.
5. Support the conduct of periodic reviews and offer expertise in re-validation and change control assessments for validated systems.
6. Support audits and inspections by regulatory agencies, supplying authoritative validation documentation and responses as needed.
7. Identify, investigate, and offer solutions for resolving deviations, non-conformances, and CAPAs related to computerised systems.
8. Maintain up-to-date knowledge of relevant regulations, guidelines, and industry best practices, and share insights to enhance organisational compliance and performance.
9. Support the delivery of a global CSV plan in collaboration with Business, Technology and Quality teams.
10. Contribute to the continuous improvement of CSV processes.
11. Assist in training the business and continually communicate the importance of CSV requirements.
12. Promote a culture of quality excellence that encourages ethical conduct and commitment to compliance.
13. This role will involve significant international interaction and some international travel.
QUALIFICATION, EXPERIENCE & SKILLS REQUIRED
14. Bachelor’s degree (or higher) in Engineering, Computer Science, Life Sciences, or a related field.
15. Hands-on experience in Computer System Validation within the pharmaceutical or healthcare industry.
16. Comprehensive understanding of GxP regulations, GAMP 5, FDA 21 CFR Part 11, CSA, and EU Annex 11.
17. Understanding of data integrity, familiar with MHRA GxP Data Integrity Guidance.
18. Good level of IT fluency, able to understand complex systems, architecture and connectivity.
19. Proven experience with validation lifecycle documentation and execution.
20. Strong knowledge of risk-based validation approaches and change control processes.
21. Regulatory, customer and commercial focus, able to ensure requirements of all parties are understood and delivered.
22. Excellent, adaptable, written and verbal communication skills.
23. Ability to work independently and collaboratively in cross-functional teams.
24. Strong organisational and time management skills with some project management experience.
Uniphar Background
Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. With a workforce of more than 3,000 spread across Ireland, United Kingdom, Mainland Europe, MENA and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines and treatments around the world.
Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Uniphar Supply Chain & Retail, Uniphar Medtech and Uniphar Pharma
Culture at Uniphar
From our leadership team and across all of our divisions, Uniphar lives and breathes four key culture pillars:
1.We have a People First approach, we do the right thing and take a stand for our people.
2.We foster a strong Entrepreneurial Spirit where Adaptability, Commitment & Resilience is embodied in our way of working.
3.We have a Common Purpose that connects our diversified businesses and people.
4. Finally, Trust is at the heart of how we operate.
How we’d like to work together
As we are a global team, there is flexibility to be based in one of Uniphar’s offices or work from home. There may be a need for face to face meetings in other locations, as needed. There may also some flexibility required in order to interact with colleagues or clients in their time zones (i.e. it’s not a ‘9 to 5’ type of job). In return, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it through our Hybrid Working philosophy.
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