LabWare 8 Consultant

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We are seeking a highly skilled LabWare Consultant to lead the configuration and deployment of LabWare LIMS Version 8 as part of a strategic upgrade from Version 6. This role is critical to supporting Quality Control (QC) operations in a regulated pharmaceutical manufacturing environment. The ideal candidate will have deep experience with LabWare in GMP settings and a strong understanding of QC workflows, data integrity, and compliance requirements.

Key Responsibilities:

• Lead the end-to-end configuration of LabWare LIMS v8 to support QC testing, stability studies, environmental monitoring, and batch release processes.

• Analyze and migrate existing LabWare v6 configurations, workflows, and custom scripts to v8, ensuring alignment with current business and regulatory requirements.

• Collaborate with QC analysts, QA, IT, and manufacturing stakeholders to gather requirements and translate them into functional LIMS configurations.

• Develop and validate master data, specifications, test plans, and result entry templates tailored to pharmaceutical QC needs.

• Support integration with laboratory instruments, ERP systems (e.g., SAP), and other digital platforms.

• Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and data integrity standards throughout the upgrade lifecycle.

• Author and execute validation documentation (IQ/OQ/PQ) in collaboration with QA and CSV teams.

• Provide training and support to QC users and system administrators post-deployment.

Required Qualifications:

• 5+ years of hands-on experience with LabWare LIMS, including configuration, scripting, and system administration.

• LabWare certification and proven experience upgrading from LabWare v6 to v8 in a GMP-regulated pharmaceutical environment.

• Strong understanding of pharmaceutical QC processes, including raw material testing, in-process testing, final product release, and stability testing.

• Experience with instrument integration (e.g., Empower, CDS, balances) and interfacing with manufacturing systems.

• Familiarity with SQL, Crystal Reports, and LabWare-specific scripting tools (e.g., LIMS Basic, Visual Workflows).

• Excellent communication skills and ability to work cross-functionally in a matrixed organization.

Preferred Qualifications:

• LabWare Certification or formal training.

• Experience with LabWare ELN, LES, or mobile modules.

• Knowledge of Lean Lab or digital transformation initiatives in pharma manufacturing.