Computer Systems Engineer

Ethypharm Group; Vigo; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading international pharmaceutical company is recruiting a Computer Systems Engineer to oversee IT systems and ensure compliance with regulatory standards. Candidates must have extensive experience in IT infrastructure and a strong understanding of 21 CFR Part 11 and GxP regulations. The role primarily focuses on maintaining manufacturing systems and supporting compliance audits, while fostering a proactive approach to problem-solving.

Servicios

25 days annual leave, increasing to 30 with service

Holiday Buy/Sell option for up to 5 days

5% discretionary bonus scheme

Bravo Benefits Platform with various discounts

Private Healthcare and Medicash health plan

Formación

• 5+ years of experience in a similar role.
• Experience with FDA, GxP, and EU Annex 11 regulations.
• Knowledge of software quality and validation methodologies.

Responsabilidades

• Oversee validation of computerized systems for compliance with regulations.
• Lead technical infrastructure support for manufacturing systems.
• Ensure computerized systems are audit-ready and assist in audits.

Conocimientos

IT infrastructure

Computer systems validation

Data integrity

problem-solving

Educación

Bachelor’s degree in Computer Science, Engineering, Life Sciences

Herramientas

VMware vSphere

Microsoft SQL

SCADA systems

Descripción del empleo

We are recruiting a Computer Systems Engineer!

The Computer Systems Engineer will be responsible for ensuring the site IT environment for manufacturing and testing activities is fit for purpose and complies with the requirements for computerized systems in the pharmaceutical industry, ensuring they meet FDA, EMA, and other regulatory standards. The ideal candidate will have strong experience in IT infrastructure, manufacturing, and laboratory systems setup, Annex 11, and related industry standards, ensuring the highest levels of data integrity and compliance.

Day-to-day responsibilities

• Provide technical infrastructure support for manufacturing systems
• Lead and execute validation of computerized systems in compliance with 21 CFR Part 11, GxP, and other applicable regulations and standards
• Ensure computerized systems are audit-ready, participate in audits, and provide documentation for regulatory inspections
• Oversee the entire lifecycle of computerized systems, including requirements gathering, DQ, IQ, OQ, PQ, and periodic reviews
• Investigate, report, and resolve system deviations, issues, or non-conformances, ensuring corrective actions
• Lead build / configuration and deployment of technology solutions for manufacturing and laboratory systems, including support pre- and post-implementation
• Create, maintain, and ensure compliance of policies, SOPs, and documentation for site IT activities
• Maintain site IT systems with vendor licenses and contracts

Skills / Experience

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or equivalent experience
• Minimum 5 years in a similar role
• At least 5 years' experience in IT infrastructure : VMware vSphere, Data backup / recovery, Microsoft SQL
• Experience with 21 CFR Part 11, EU Annex 11, GxP, and FDA regulations
• Knowledge of computer systems validation methodologies
• Knowledge of software quality and validation (e.g., GAMP)
• Knowledge of SCADA systems

About you

You are a proactive problem-solver with a strong understanding of computer systems architecture, networks, and software integration. You have a keen eye for detail and a collaborative mindset, thriving in dynamic environments and designing / supporting robust, efficient systems to ensure smooth operations.

What we offer

• 25 days annual leave, increasing to 30 with service, plus bank holidays
• Holiday Buy / Sell option for up to 5 days
• 5% discretionary bonus scheme
• Bravo Benefits Platform with discounts, financial support, wellbeing apps, and more
• Salary Sacrifice for Electric Vehicles via Tusker
• Private Healthcare and Medicash health cash plan

Working hours

• Monday - Friday, 8 : 30 am - 5 pm, with some travel expected
• Onsite role with flexible work from home options
• Based at our Romford site

Please note : We are currently unable to assist with sponsorship for right to work.

Why Ethypharm?

Ethypharm is a leading international pharmaceutical company focused on hospital care, CNS, and internal medicines, with six production sites across France, the UK, Spain, and China. Join us in improving patients’ lives at our modern Romford facility, located 20 miles from London, dedicated to high-quality pharmaceutical manufacturing.

We value diversity and provide equal opportunities, open to flexible working arrangements to meet business needs.

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