Jobs at MSD Animal Health Technology Labs

Provides IT compliance and validation support for computerized systems at a biologics manufacturing site. Responsibilities include CSV and SDLC compliance, data integrity, cybersecurity controls, change controls, periodic reviews, access administration, disaster recovery, incident investigations, CAPAs, audit support, training, and inspection readiness. The role serves as a subject matter expert and liaison for auditors while supporting regulatory compliance under GxP, EU Annex 11, 21 CFR Part 11, GMP, and SOX requirements.

Ensures computerized systems, data management processes, and system development activities comply with GxP, CSV, data integrity, cybersecurity, and regulatory requirements. Manages validation and compliance activities, including change controls, periodic reviews, access management, disaster recovery, deviations, CAPAs, audits, inspections, and training. Serves as a compliance and validation subject matter expert while maintaining continuous inspection readiness across a biologics manufacturing site.

Lead a multi-site laboratory Quality Management System across the UK, Ireland, and United States. Harmonize quality procedures, documentation, audits, CAPA, accreditation activities, change management, and continuous improvement. Monitor quality metrics, manage auditor relationships, apply risk-based principles, and coach site Quality Representatives. Requires international collaboration and 15–20% travel.

Supports biologics manufacturing science and technology activities across upstream or downstream processing. Responsibilities include process qualification and validation, development and PPQ batches, technology transfer, change controls, investigations, CAPA, audits, process monitoring, experimental design, data analysis, regulatory documentation, troubleshooting, and continuous improvement using Lean Six Sigma. The role supports equipment qualification, commercialization, compliance, safety, and reliable drug substance supply.

Provides senior automation support for biologics manufacturing systems, including DeltaV, PLC/HMI/SCADA platforms, OEM systems, historians, and digital manufacturing technologies. Troubleshoots process control issues, leads change controls, supports validation and qualification, contributes to product launches and digital transformation, and collaborates across Manufacturing, Quality, Engineering, IT, and Digital teams. Mentors colleagues and promotes compliant, reliable, and continuously improving manufacturing operations.

Leads cross-site, cross-functional launch excellence and transformation initiatives supporting new product introduction and receiving unit readiness across a biologics manufacturing network. Drives process improvements, KPI measurement, root-cause analysis, Kaizen, A3, and PDCA activities; converts lessons learned into procedures, best practices, and standard schedules. Partners with stakeholders and project scheduling teams to improve launch execution while maintaining quality, safety, cost, resource, and timing objectives.