• Support detailed business case and project justification to support the capital expenditure for a large biotech renovation/ construction project.
• Support the development of comprehensive project plans, including scope, schedule, WBS, and budget.
• Identify and deploy resource and project needs across the project lifecycle.
• Coordinate with internal teams, external stakeholders, and vendors to ensure project objectives are met.
• Support conceptual and feasibility assessments and requirements.
• Oversee the design, renovation and construction of production, warehouse, filling, and gowning spaces, to include Personnel and Material Air Locks.
• Prepare technical documentation such as drawings, specifications, and reports.
• Identify and support permitting requirements, as needed. 
• Monitor project progress, identify, and escalate potential risks, and recommend solutions to mitigate issues.
• Support procurement activities, including sourcing communicating with suppliers/vendors.
• Ensure compliance with Quality, EHS, and Client company policies.
• Maintain clear communication with team members, contractors, and clients.
• Prepare regular status updates and progress reports for project stakeholders.
• Assist in commissioning and qualification phases to verify system performance and compliance.
• At least 7 years in a project engineering or project management role within an FDA regulated production facility. 
• Proven experience and expert knowledge in the use of project management tools and methodologies including SAP.
• Proven understanding of the project lifecycle and FEL process.
• Proven ability to influence decision making with executive level stakeholders.
• Proven exceptional social and diplomacy skills.
• Proven ability to lead and manage a team across a multi-departmental project with direct and indirect management of functional resources.
• Fully leveraging the power of Microsoft platforms to support team collaboration and communication.

Bachelor’s degree in an engineering field (Mechanical, Chemical, Biomedical preferred).