GxP IT Project Lead: ERP, LIMS & MES

August Bioservices; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

August Bioservices in Nashville, TN seeks an IT Project Manager to plan, coordinate and execute enterprise IT initiatives across GxP, manufacturing, quality and lab systems. You will lead end-to-end projects for ERP, LIMS, Data Historian, MES/eBR and related platforms, ensuring alignment with timelines, budgets and regulatory expectations.

The ideal candidate has 5+ years delivering cross-functional technology projects within pharmaceutical or CDMO environments, strong stakeholder management and

Qualifications

• Bachelor’s degree in IT/CS/Engineering/Business, or related discipline.
• 5+ years of progressive experience in IT, digital transformation, enterprise application, manufacturing technology, or engineering technology projects.
• Experience managing projects involving SCADA, Data Historian, MES, BMS, EMS, or automation systems.
• Experience in regulated life sciences environments (pharma, biotech, CDMO) is strongly preferred.
• Ability to translate technical concepts into business-focused outcomes and lead cross-functional teams.

Responsibilities

• Lead end-to-end project management for ERP, LIMS, Data Historian, MES/eBR and other enterprise IT systems initiatives from planning to deployment and post-implementation support.
• Build and maintain project charters, plans, milestones, budgets, RAID logs, decision logs, and status reports.
• Coordinate activities across IT, Engineering, Automation, Manufacturing, Quality, Validation, Laboratory Operations, Supply Chain, Finance, and other business functions.
• Develop and maintain detailed project plans, status reports, KPIs and executive dashboards.
• Work with SMEs to ensure project requirements, scope, deliverables, responsibilities, and success criteria are clearly defined.
• Track schedules, dependencies, milestones, deliverables, and resources to ensure timely completion.
• Identify risks and issues and drive mitigation, escalation, and resolution.
• Manage third-party vendors, software providers, consultants, and system integrators.
• Monitor vendor performance against scope, schedule, and contractual commitments.
• Coordinate CSV and CSA activities for GxP-regulated systems with Quality and Validation teams.
• Ensure required project and validation documentation is completed per procedures and regulatory expectations.
• Support prioritization and resource planning across multiple concurrent IT projects.
• Manage interdependencies between enterprise, manufacturing, laboratory systems, infrastructure, cybersecurity, and data platforms.
• Ensure smooth transition of completed projects to system owners and support teams.

Skills

Project management

Cross-functional leadership

Regulatory awareness

Stakeholder management

Communication

Budgeting & forecasting

Risk management

Vendor management

Education

Bachelor’s degree in IT/CS/Engineering/Business

Tools

ERP Systems

LIMS

SCADA

Data Historian

MES/eBR

Job description

August Bioservices in Nashville, TN seeks an IT Project Manager to plan, coordinate and execute enterprise IT initiatives across GxP, manufacturing, quality and lab systems. You will lead end-to-end projects for ERP, LIMS, Data Historian, MES/eBR and related platforms, ensuring alignment with timelines, budgets and regulatory expectations.

The ideal candidate has 5+ years delivering cross-functional technology projects within pharmaceutical or CDMO environments, strong stakeholder management and