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Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead and oversee Digital Lab initiatives, including LIMS, ELN, and LES implementations, upgrades, and optimizations in regulated laboratory environments
- Elicit, analyze, and document business requirements for LIMS implementations/enhancements (LabWare, Benchling, STARLIMS), translating laboratory processes into functional specifications and user stories.
- Act as the bridge between business and technical teams, ensuring accurate mapping of lab workflows (sample management, testing, stability, reporting) into system configurations and solution designs.
- Drive process optimization and standardization by identifying gaps, redundancies, and improvement opportunities across laboratory operations and aligning with industry best practices.
- Support system implementation and validation activities by defining test scenarios, coordinating UAT, ensuring traceability, and maintaining compliance with GxP, 21 CFR Part 11, and data integrity requirements.
- Facilitate stakeholder engagement and change management through workshops, training, documentation, and user support to drive adoption of LIMS solutions across labs.
- Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations
- Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms
- Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs
- Guide clients through CSV / CSA / risk‑based validation activities for digital lab systems
- Support audits, inspections, and regulatory assessments related to laboratory systems
- Identify opportunities for process harmonization, standardization, and digital enablement across laboratories
- Lead, coach, and mentor Digital Lab consultants, validation analysts, and technical team members
- Manage work allocation across LIMS, ELN, and LES engagements, ensuring quality delivery and adherence to timelines
- Conduct performance reviews, feedback, and development planning
- Build and strengthen Digital Lab and laboratory systems capabilities within the team
- Support hiring, onboarding, training, and knowledge‑transfer initiatives
- Foster a culture of quality, accountability, and continuous improvement.
- Make informed decisions on delivery approach, validation strategy, and risk mitigation for digital lab programs
- Assess system, data, and compliance risks and proactively escalate issues to clients and EY leadership.
- Contribute to business development, proposals, and client presentations related to Digital Lab initiatives.
Requirements
What you’ll need- 8–12 years of experience in Digital Lab, LIMS, ELN, LES, or regulated laboratory systems
- Proven experience leading or supporting digital lab implementations, upgrades, or validation initiatives
- Experience working in regulated GxP environments, supporting audits and inspections
- Demonstrated experience managing teams, vendors, or complex stakeholders
- Strong documentation discipline and familiarity with controlled quality systems
- Ability to operate at a managerial level, balancing delivery and people leadership
- Certifications such as Labware Configuration, Sample Manager developer, Computer System Validation (CSV/CSA), or Project Management Professional (PMP) are ideal.
- Experience with global or multi-site digital laboratory implementations, upgrades, and inspection-readiness activities.
- Familiarity with emerging technologies in laboratory operations, including automation, analytics, and AI/ML-enabled solutions.
- Knowledge of data integrity principles, electronic records and signatures, and structured laboratory data management.
- Experience with industry-leading digital lab platforms such as LabWare, SampleManager, STARLIMS, Benchling, or equivalent systems.
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
LIMSELNLESLabWareSTARLIMSBenchlingData IntegrityProcess OptimizationRequirements GatheringSystem Configuration
Soft Skills
Stakeholder EngagementChange ManagementDocumentation DisciplineCoachingContinuous Improvement
Certifications
Labware ConfigurationSample Manager DeveloperComputer System ValidationProject Management Professional