LabWare LIMS system

Provide expertise and guidance to the Business and other laboratory system groups in the planning, use, and adoption of the LabWare LIMS system (EM, Sample, Lot Manager, Stability).

Review and Assessment of risk as well as work with QA to ensure accuracy and timeliness for change management.

Transform business requirements into detailed designs that can be implemented.

Manage, direct, and review design and deliverables of developers throughout the software development phase.

Perform functional validation activities including IQ/OQ/PQ and master document review, executing, and reviewing deployments of all system changes.

Manage on-time completion of controlled documents (Calc protocols, Stored Queries, UATs etc.)

Monitoring deviations and IT CAPAs initiation, action processing, root cause analysis.

Ensure the content of all documentation and training material is technically correct.

Participate/lead internal team meetings as well as with the business.

Identify and implement process improvements for the team.

Coordinate with LIMS Support and LIMS Administration to set priorities for problem resolution.

Provide level 3 production support as needed.

Support site LIMS team during internal and regulatory GMP system audits.

Knowledge, Experience and Skills:

Bachelor of Science Degree in Computer Science, Information Systems, Biotechnology, or related science/engineering/computer science with 5 years of relevant industry experience.

LabWare LIMS Administration certified preferred.

Experience in all phases of software development life cycle (SDLC) introducing medium-to-large-scale change in a corporate environment.

Experience managing, directing, and coordinating the work of subordinate staff preferred.

Strong laboratory informatics software and application (specifically LIMS) knowledge and of relevant technologies/architectures.

Experience in Global LabWare LIMS rollouts, especially LW8 is preferred.

Experience using databases and/or data trending/analysis tools (Microsoft Access, statistical programs) and basic coding capability (such as SQL, R, Python) is preferred.

Experience with commercial biologics is preferred.

Strong analytical, problem-solving, and conceptual skills.

Good verbal and written communication skills.

Background in the Pharmaceutical industry preferred.

Solid knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, and other regulatory requirements preferred. "