Global Quality Junior 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
Assist in the development, implementation, and maintenance of Computer System Validation (CSV) documentation in compliance with regulatory requirements and Good Practice (GxP) standards.
Support the validation of computerized systems across the company.
Participate in risk assessments and impact analyses for new and existing computer systems.
Collaborate with cross-functional teams such as Operational Quality, IT, Operations, Project Management and Test teams to ensure systems meet user requirements and regulatory guidelines.
Assist with deviation investigations, change controls, and corrective and preventive action (CAPA) processes related to CSV activities.
Remain up-to-date with the latest regulations, guidance documents, and industry best practices related to CSV and governing regulations.
Support audits and inspections by providing relevant CSV documentation and expertise.
Support the delivery of CSV projects with basic project management skills.
Support the delivery of a global CSV plan in collaboration with Business, Technology and Quality teams.
Contribute to the continuous improvement of CSV processes.
Promote a culture of quality excellence that encourages ethical conduct and commitment to compliance.
This role will involve some international interaction and some international travel.
QUALIFICATION, EXPERIENCE & SKILLS REQUIRED
Suitable for Graduate with Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
Familiarity with GxP regulations (GMP, GDP, GCP, etc.) and their impact on computerised systems.
Excellent written and verbal communication skills, with the ability to produce clear and concise technical documentation.
Strong analytical and problem-solving abilities.
Ability to work both independently and collaboratively within a team environment.
Attention to detail and a commitment to maintaining high-quality standards.
QUALIFICATION, EXPERIENCE & SKILLS DESIRABLE
Previous experience (e.g., internship, placement, or project) in a pharmaceutical or regulated environment.
Knowledge of software development lifecycles, IT infrastructure, or data integrity principles.
Understanding of risk management and change control processes.
Familiarity with audit processes and regulatory inspections.
Proficiency with electronic systems such as document management systems, SDLC management systems, testing systems.
Strong organisational skills with the ability to manage multiple tasks and priorities.
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.
Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses.
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Top Skills
What We Do
Uniphar is a diversified healthcare services organisation with activities in Ireland, UK, Europe, the USA and APAC
