Merck Life Science
Global GxP System Engineer
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Work Your Magic with LSA Systems Administrator & GxP Governance Lead
Our colleagues across the globe love innovating with science and technology to enrich people’s lives. We are passionate about delivering impact in Healthcare, Life Science, and Electronics. We know you’ve got big plans—so do we! That’s why we’re always looking for curious minds who see themselves imagining the unimaginable.
The Team
The LSA (Laboratory Systems Administration) team owns the lifecycle management of Lab software systems. This includes:
- Installation and configuration
- User access management
- Audit trails and data integrity reviews
- Password reset and first-line support
The Role
As the GxP Computer Systems Lifecycle Governance Lead, you’ll:
- Drive end-to-end lifecycle governance of GxP computer systems, ensuring regulatory compliance, data integrity, and operational resilience in a global environment.
- Lead cross-functional project teams and shape process improvements as a trusted subject-matter expert for Operations, IT, Quality Assurance, and Development Services.
- Reduce compliance risk, improve service quality, and enhance global team productivity.
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Key Responsibilities:
- Ownership of GxP system lifecycle activities including:
- Installation, configuration, and setup
- User access management and storage
- Change management and training
- SOP governance, CAPA management
- Disaster recovery, business continuity
- Data integrity assessments
- Continuous improvement of GxP system processes across global operations
- Mentorship of junior team members to build team capability
Who You Are
- Qualification: Degree in a science or technical discipline (or equivalent regulated IT/life sciences experience)
- Experience:
- 5+ years in GxP-regulated environments (e.g. pharmaceutical/biotechnology)
- Hands-on lifecycle management of GLP/GMP computer systems
- Regulatory Insight:
- Expertise in 21 CFR Part 11, Eudralex Vol 4 (Annex 11/15), ICH Q7–Q10, GAMP 5, CSA, ALCOA+
- Technical Proficiency:
- Systems: LIMS, Oracle, BRIQS,BMRAM (advantageous)
- User access governance, configuration management, OS upgrades, patch management
- Validation, audits, change control, decommissioning
- Stakeholder Collaboration: Clarity in communicating complex technical content to Operations, IT, and Quality Assurance
- Modern Best Practices:
- Regulatory compliance: FDA (cGMP/GLP), EU requirements, MHRA guidance
- Agile problem-solving in global teams
- Quality-first mindset with integrity
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What We Offer
We enrich Humanity by sparking discovery— across diverse, innovative minds. Our promise:
- Inclusion culture: Champion equality, belonging, and growth at your own pace
- Curiosity-driven careers: We value variety in backgrounds and innovation in progress
- Meaningful impact: Shape science and tech to enhance millions of lives daily
Apply now and deploy your work magic— join us in sparking discovery! 🔥
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