Job Description
Job Summary:
Manage all the IT components related to the commissioning the Biomanufacturing Plant to a fully qualified GMP facility. This role requires strong leadership, organizational, communication skills to ensure that all the deliverables are tracked and completed on time, within scope and on budget. The Project Manager will work closely with cross-functional teams, stakeholders, and external partners.
Key Responsibilities:
- Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets.
- Lead project teams to meet quality and compliance standards (GMP), ensuring timely execution.
- Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication and alignment on project goals.
- Manage project resources, including personnel, budget, and technology, to support project success.
- Maintain project documentation, including status reports, project charters, and other relevant documents.
- Author or revise and manage the review and approval of various validation documents, SOPs, and WI required for the project.
- Work with the various business functions to draft/update user requirements of relevant IT systems to satisfy the business needs to support the process and GMP use of the facility.
- Coordinate impact assessments to identify risks of the various IT implementation with respect to regulatory and security measures.
- Identify potential risks associated with GMP facility and systems projects and develop mitigation strategies.
- Manage the testing (IQ/OQ, System Testing, UAT, Instrument Qualification, etc.) required for the project. This includes developing, execution, review and approval of test scripts.
- Implement change management strategies and communicate project changes as needed.
- Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of laboratory instruments and IT systems.
- Assist in updating any knowledge base articles.
Qualifications:
- Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 5 years’ experience
- 5+ years of project management experience within a GMP-regulated environment, ideally in pharmaceutical or biopharmaceutical manufacturing.
- Experience developing and deploying IT systems (Experience in Labvantage LIMS/ELN, Veeva, Building Automation System, Environmental Management System is a plus)
- Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
- Demonstrated ability to work independently to complete assignments within defined time constraints.
- Ability to interpret and apply GxPs, regulatory requirements
- Must have knowledge of software development lifecycle (SDLC) and of computer systems validation (CSV)
- Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail oriented
- Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
- Strong interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
- Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations
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