Computer Systems Engineer

Ethypharm; Romford; On-site; GBP 45,000 - 65,000; Full time

Job summary

Ethypharm is seeking a Computer Systems Engineer for their Romford facility. The successful candidate will ensure the IT environment meets regulatory standards within a pharmaceutical context, providing infrastructure support and leading systems validation. This role requires proactive problem-solving and a strong technical background in manufacturing and laboratory systems.

Benefits

25 days annual leave, rising to 30 with length of service

Holiday Buy/Sell option for additional leave

5% Bonus scheme

Bravo Benefits Platform

Salary Sacrifice scheme for Electric vehicles

Private Healthcare with Medicash health cash plan

Qualifications

• Minimum 5 years of experience in a similar role.
• Experience with 21 CFR Part 11, EU Annex 11, GxP, and FDA regulations.
• Knowledge of software quality validation methodologies.

Responsibilities

• Provide technical infrastructure support for manufacturing systems.
• Lead and execute validation of computerized systems.
• Ensure audit readiness and participate in regulatory inspections.

Skills

Problem-solving

Attention to detail

Computer systems architecture

Software integration

Education

Bachelor's degree in Computer Science, Engineering, or Life Sciences

Tools

VMware vSphere

Microsoft SQL

SCADA

Job description

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We are recruiting a Computer Systems Engineer!

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

Day-to-day responsibilities

• Provide technical infrastructure support for the manufacturing systems
• Lead and execute the validation of computerised systems in compliance with 21 CFR Part 11, GxP, and other applicable regulations and standards
• Ensure that computerised systems are always audit-ready. Participate in internal and external audits and provide necessary documentation for regulatory inspections
• Oversee the entire lifecycle of computerised systems, including requirements gathering, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and periodic reviews
• Investigate, report, and resolve any system deviations, issues, or non-conformances, ensuring appropriate corrective actions are taken
• Lead the build/configuration and deployment of technology solutions for all manufacturing and laboratory systems, including pre- and post-implementation support
• Responsible for the creation, maintenance and compliance with standards Policies, SOPs and associated documents for the site-based IT activities
• Maintain the site IT systems with vendor licenses and contract condition

Skills/Experience

• Bachelor's degree in an appropriate discipline (Computer Science, Engineering, Life Sciences) or equivalent experience
• Minimum of 5 years of experience in a similar role
• At least 5 year's experience in IT infrastructure: VMware vSphere, Data backup and recovery, Microsoft SQL
• Experience with 21 CFR Part 11, EU Annex 11, GxP and FDA regulations
• Knowledge of Computerised systems validation methodologies
• Knowledge of Software quality and validation (e.g., Good Automated Manufacturing Practice GAMP).
• Knowledge of SCADA (Supervisory Control and Data Acquisition)

About you

You're a proactive problem-solver with a strong understanding of computer systems architecture, networks, and software integration. With a keen eye for detail and a collaborative mindset, you thrive in dynamic environments and take pride in designing and supporting robust, efficient systems that keep operations running smoothly.

What we offer you

• 25 days annual leave, rising to 30 with length of service plus bank holidays (prorated)
• Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days of holiday
• 5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
• Bravo Benefits Platform - offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more
• Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
• Private Healthcare with an additional Medicash health cash plan

Working hours information

• Monday - Friday, 8.30am - 5pm. Please note travel may be required.
• This is an onsite role, however there is some flexibility to work from home.
• This role will be based at our Romford site.

Please note, at present, we are unable to assist with sponsorship for right to work.

Why Ethypharm?

Ethypharm is a leading mid-sized international pharmaceutical company, with strong European roots, that manufactures and provides essential medicines, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain,
and China have expertise in injectables and complex oral solid forms.

At Ethypharm, you will be a part of a team dedicated and committed to improving patients' lives.

Our Romford facility is located 20 miles from the centre of London and consists of over 6700 square metres of a high-quality, modern pharmaceutical facility where we mix, fill, sterilise, inspect, pack, and label a wide range of medicines.

At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.