Technical Specialist, Computerised System Validation (CSV)

CompanyPharmaron

LocationRushden, England, United Kingdom

Posted At11/5/2025

UK Visa Sponsorship Analytics

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Occupation Type

IT business analysts, architects and systems designers

Occupation Code Skill LevelHigher Skilled

Sponsorship Salary Threshold

£54,900 (£28.15 per hour)

Occupation rate applies

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Description

Job Introduction

Technical Specialist, CSV

(Rushden (Northamptonshire)

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 sites across the UK, US and China, and we support drug discovery through to manufacturing with fully integrated, high-quality services.

We’re proud of the impact we make—just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to gene therapies, and we work with more than 3,000 global customers.

Pharmaron is excited to offer an opportunity for a CSV Technical Specialist to join our dynamic team at the Rushden Metabolism facility. In this pivotal role, you'll play a key part in ensuring our computer systems meet the highest standards of validation and compliance, aligned with GAMP 5, GLP, GCP, and internal quality expectations. If you're passionate about driving excellence in system integrity and compliance, we’d love to hear from you!

Please note:

Unfortunately, we are unable to offer visa sponsorship for this position, now or in the future. Candidates must have the right to work in the UK at the time of application.

At Pharmaron we offer:

Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!

Key roles and responsibilities:

Responsible for managing projects related to computerised system validation and perform the data integrity assessments in Metabolism department.
Write and execute the GxP system lifecycle documentation including the System Risk assessment, Validation Plan, User Requirements Specifications, Vendor Assessment, Configuration Specifications / Verification, Testing Protocols / Scripts , Risk Assessment, Traceability Matrix, User Acceptance Testing, Validation Reports, Compliance assessment and SOPs.

Responsible for the systems, Instrument, software’s data integrity assessment.

Solve the problems during the validation process and able to handle and close out of the incidents, deviations and change controls during the validation process.

Actively collaborate with project stakeholders and the IT team to define the needs of projects.

Ensure complete and accurate documentation of computerised system lifecycle is available, maintaining clear records and compliance.

Ensure that system validation SOPs align with Regulatory Requirements and Industry standards.

Participate in Sponsor and Regulatory Audits.

Support the administration and operation of Computerised systems.

Requirements:

MSc or BSc in Chemistry/Biochemistry/ Biomedical Sciences or related subject or a qualification in Computer Science
Working knowledge and good hands on the end-to-end CSV projects.
Proficient Knowledge of CSV Principles and GAMP 5 requirements to facilitate changes and system improvements.
Good understanding of the requirements of the Data integrity.
Good understanding of the Laboratory systems, instrument, and software’s. (Desired but not mandatory).

Good understanding of the GLP and GCP Guidelines and Regulations. (Desired but not mandatory).

Effective communication skills both written and oral are required to communicate with colleagues and a wider audience.

Excellent computer literacy skills are essential as work will be heavily focused on software and applications

Knowledge of quality/regulatory standards and quality systems (in particular the relationship of the MHRA with the pharmaceutical industry) is desirable.

Our Company:

“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.

Based in Northamptonshire, our Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate, Plant Metabolism and Metabolite Identification) in addition to Chemistry (which includes API and IMP manufacture). We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential.

We offer a competitive salary and a progressive and comprehensive suite of employee benefits.

We offer state of the art working environment in our specialist Rushen site.

We offer the opportunity for growth and development and will support funding for relevant training and development programmes.

Why Should You Apply?

This is an opportunity for you as a CSV professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
Build and shape your career in an environment that sets and commits to the highest standards of Chemistry.
To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.