Now hiring

Global GxP System Engineer @ Merck Group

Glasgow, Glasgow, United KingdomOnsiteFull-timePosted 19 days ago

Opens on the employer's site

About this role

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Team The LSA (Laboratory Systems Administration) team are responsible for the lifecycle management of Lab software systems, specifically for the installation, configuration , user access, audit trail and data integrity/lifecycle reviews, password resets and general first line support for those systems. The Role In this pivotal role, you will own and drive the end-to-end lifecycle governance of GxP computer systems and business-managed applications across a global operating environment — ensuring regulatory compliance, data integrity, and operational resilience at every stage. You will lead cross-functional project teams, shape process improvements, and serve as a trusted subject-matter authority for stakeholders across Operations, IT, Quality Assurance, and Development Services. Your work will directly reduce compliance risk, improve service quality, and enable colleagues worldwide to focus on high-value activities. You will take full ownership of GxP system lifecycle activities — installation, configuration, set up user access, data storage locations, change management, training in systems admin for the wider LSA team and of users in alignment with updates/changes, SOP governance, CAPA management, disaster recovery, business continuity, and data integrity assessments — while identifying and implementing opportunities to advance GxP system processes. You will also mentor and guide junior team members, contributing to the growth and capability of the broader team. Who You Are

• You hold a degree in a science or technical discipline, or bring equivalent professional experience in a regulated IT or life sciences environment. • You have at least 5 years hands-on experience of administration of computer system lifecycle management in GxP-regulated environments within the pharmaceutical or biotechnology industry. • You bring deep knowledge of applicable regulatory frameworks and industry standards, including 21 CFR Part 11, Eudralex Volume 4 (Annex 11 & Annex 15), ICH Q7–Q10, GAMP 5, Computer Software Assurance (CSA), and ALCOA+. • You have practical experience managing GxP system administration, user access governance, configuration management, infrastructure support (including OS upgrades and patch management), and data integrity controls. • Experience in systems such as LIMS, ORACLE, BRIQS and BM-RAM would be advantageous

• You are experienced in leading cross-functional teams through validation, change management, periodic review, and system decommissioning activities, and you communicate complex technical content clearly to diverse stakeholders. • You have a track record of supporting or leading regulatory inspections and audits related to GxP computer systems, including the management of CAPAs and corrective actions. • You apply a quality-first mindset, act with integrity, and bring the agility to drive and embrace change across global teams and processes. • You are proficient in applying FDA and EU regulatory requirements (cGMP, GLP) and advanced data integrity guidance from bodies including the MHRA and

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Skills

gxp system lifecycle managementregulatory compliancecomputer system administrationsop governancecapa managementdisaster recoverybusiness continuitydata integrity assessmentchange managementconfiguration managementuser access governancelimsoraclebriqsbm-ram

Ready to apply?

Install the ResuMinder extension and we'll auto-fill the application in seconds — no rewriting.

Get the extension →
See how your CV scores
Global GxP System Engineer at Merck Group | ResuMinder Jobs