Position Overview
This position delivers technical support within the digital lab systems team, focusing on the setup, maintenance, and governance of LIMS static and master data. Supporting global Quality Control (QC) operations, the role ensures digital system alignment across new product introductions, commercial manufacturing, stability studies, and analytical method transfers.
The specialist verifies that system configurations comply with standard operating procedures, specifications, sampling plans, and regulatory data standards covering raw materials, water testing, environmental monitoring, micro testing, and biologics release. Additionally, this position provides direct, daily troubleshooting support to laboratory staff to maintain uninterrupted batch release timelines and operational workflow.
Key Responsibilities
- Master Data Management: Configure, build, and maintain LIMS static/master data following established corporate standards and standardized change management protocols.
- Change Control Execution: Manage change requests within enterprise lab software, evaluating system dependencies, cross-functional impacts, and interface integrity.
- Stakeholder Collaboration: Partner with QC analysts and laboratory leadership to accurately capture testing workflows and requirements within system configurations.
- Testing & User Acceptance (UAT): Conduct preliminary dry runs, gather end-user feedback, and execute User Acceptance Testing (UAT) for system upgrades, patches, and feature additions.
- Continuous Improvement: Support operational excellence initiatives by configuring features that track key performance indicators (KPIs), testing metrics, and lean laboratory queues.
- User Support & Escalation: Provide responsive technical assistance to laboratory personnel regarding system errors, data entry issues, and workflow queries.
- Documentation & Training: Author, revise, and review procedural documentation (SOPs, Work Instructions) and assist in creating user training materials.
- Project Delivery: Represent the digital lab systems team on cross-functional project squads, completing assigned deliverables on schedule.
Required Qualifications & Competencies
- Education & Experience: Bachelor's degree in a scientific, computer science, or engineering discipline with 1-3 years of experience in a regulated biopharmaceutical or life sciences environment (or equivalent combination of education and hands-on experience).
- Technical & System Knowledge: Familiarity with laboratory electronic systems (LIMS, LES, CDS/Empower, MODA, or similar enterprise databases) alongside working knowledge of basic data management concepts.
- Regulatory Compliance: Practical understanding of cGMP regulations, data integrity standards, and regulatory frameworks governing pharmaceutical testing.
- Analytical Skills: Strong analytical problem-solving capability with meticulous attention to detail and structured data verification skills.
- Communication & Collaboration: Adaptable team player with strong written and verbal communication skills, capable of liaising effectively between laboratory end-users and IT management.
- Adaptability: Demonstrated capability to manage competing priorities independently, adapt to shifting project timelines, and navigate semi-structured technical tasks.
