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Project Manager, IT at August Bioservices · Katori

Asks for

The ad says“· Working knowledge of GxP, 21 CFR Part 11, data integrity, CSV, and CSA principles.”
The ad says“· Strong risk, issue, dependency, and change-management capabilities.”
The ad says“· Excellent written, verbal, presentation, and executive communication skills.”
The ad says“· Partner with Quality and Validation teams to coordinate Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.”
The ad says“· Partner with Quality and Validation teams to coordinate Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.”
The ad says“This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.”
The ad says“This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.”
The ad says“· Working knowledge of GxP, 21 CFR Part 11, data integrity, CSV, and CSA principles.”
The ad says“This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.”
The ad says“This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.”
The ad says“· Strong project management, planning, organization, and prioritization skills.”
The ad says“· Strong project management, planning, organization, and prioritization skills.”
The ad says“· Strong project management, planning, organization, and prioritization skills.”
The ad says“· Strong project management, planning, organization, and prioritization skills.”
The ad says“· Strong risk, issue, dependency, and change-management capabilities.”
The ad says“This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.”
The ad says“· Strong stakeholder and vendor management skills.”
The ad says“· Strong stakeholder and vendor management skills.”

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The IT Project Manager is responsible for planning, coordinating and executing enterprise-wide IT initiatives with a strong emphasis on systems supporting G&A, manufacturing, engineering, laboratory, and quality functions.

This role will manage projects involving business and operational technology platforms such as ERP, LIMS, SCADA, Data Historian, MES/eBR, laboratory systems, quality systems, and other GxP-regulated applications.

The IT Project Manager will serve as the primary coordination point between business stakeholders, IT, Engineering, Manufacturing, Quality, Validation, Laboratory Operations, external vendors, and implementation partners. The role is focused on ensuring projects are properly planned, governed, resourced, tracked, and delivered in alignment with business objectives, timelines, budgets, and regulatory requirements.

The ideal candidate will have experience managing complex, cross-functional technology projects within pharmaceutical, biotechnology, CDMO, or another regulated life sciences environment.

Responsibilities:

· Lead end-to-end project management for ERP, LIMS, Data Historian, MES/eBR and other enterprise IT systems initiatives from planning and requirements gathering through deployment and post implementation support framework.

· Build and maintain project charters, project plans, schedules, milestones, budgets, resource plans, RAID logs, decision logs, and project 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 business and technical SMEs to ensure project requirements, scope, deliverables, responsibilities, and success criteria are clearly defined.

· Track project schedules, dependencies, milestones, deliverables, and resource commitments to ensure timely completion.

· Identify project risks, issues, constraints, and dependencies and drive appropriate mitigation, escalation, and resolution.

· Manage and coordinate third-party vendors, software providers, consultants, engineering firms, and system integrators.

· Monitor vendor performance against agreed scope, schedule, deliverables, and contractual commitments.

· Partner with Quality and Validation teams to coordinate Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.

· Ensure required project and validation documentation is completed in accordance with applicable procedures and regulatory expectations.

· Support prioritization and resource planning across multiple concurrent IT projects.

· Manage interdependencies between enterprise systems, manufacturing systems, laboratory systems, infrastructure, cybersecurity, and data platforms.

· Ensure completed projects transition effectively to system owners, support teams, and operational functions.

· Manage relationships with implementation partners, vendors, system integrators, consultants and internal SMEs.

Qualifications:

· Bachelor’s degree in information technology, Computer Science, Engineering, Business Administration, Project Management, or a related discipline.

· 5+ years of progressive experience in IT, digital transformation, enterprise application, manufacturing technology, or engineering technology projects.

· Experience managing manufacturing and engineering technology projects involving SCADA, Data Historian, MES, BMS, EMS, or automation systems.

· Experience managing projects within pharmaceutical, biotechnology, medical device, CDMO, or another regulated life sciences environment strongly preferred.

· Ability to translate technical concepts into business focused outcomes and leading teams, influencing decision and driving accountability across the key stakeholders.

· Strong project management, planning, organization, and prioritization skills.

· Ability to manage multiple complex and cross-functional projects simultaneously.

· Strong understanding of technology project lifecycles and project governance.

· Understanding of IT/OT environments and the coordination required between IT, Engineering, Automation, Manufacturing, and cybersecurity teams.

· Working knowledge of GxP, 21 CFR Part 11, data integrity, CSV, and CSA principles.

· Strong stakeholder and vendor management skills.

· Ability to facilitate cross-functional discussions and drive teams toward decisions and deliverables.

· Strong risk, issue, dependency, and change-management capabilities.

· Ability to communicate technical project information clearly to both technical and non-technical stakeholders.

· Excellent written, verbal, presentation, and executive communication skills.

· Ability to manage competing priorities while maintaining focus on project objectives and business outcomes.

Preferred Qualifications:

· PMP, PMI-ACP, Scrum Master, or similar project management certification.

· Experience managing projects involving ERP platforms such as Microsoft Dynamics 365, Oracle, SAP, or NetSuite.

· Experience managing laboratory system projects involving LIMS, CDS, or other laboratory informatics platforms.

· Experience managing manufacturing and engineering technology projects involving SCADA, Data Historian, MES, BMS, EMS, or automation systems.

· Experience working with system integrators, engineering firms, software vendors, and consulting partners.

· Experience with Agile, Waterfall, and hybrid project management methodologies.

This position is designated for a specific project forecasted to span across 12 months. Following the completion of the project, the Project Manager may have the opportunity to transition to a full time opportunity, however, it is not guaranteed.

We are open to candidates outside of the greater Nashville area, however, we will not be able to provide relocation assistance.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

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