Project Director

Technical Source has partnered with a client in the Greater Boston area to identify a pharmaceutical manufacturing project director for a 9 month contract on a capital project. Candidates should have deep experience in leading the greenfield and/or brownfield manufacturing projects.

Required Experience:

• Industry Experience: Minimum of 10 years of experience in project management within the pharmaceutical manufacturing industry, with a proven track record of successfully leading and delivering capital projects.
• Project Scope: Demonstrated experience in managing large-scale capital projects, including planning, execution, and closeout phases.
• Regulatory Compliance: In-depth knowledge and experience with regulatory requirements and standards in the pharmaceutical industry, including FDA, EMA, and GMP regulations.
• Leadership: Strong leadership experience, including managing and coordinating multidisciplinary teams, contractors, and suppliers.
• Budget Management: Extensive experience in budget planning, management, and cost control for large-scale projects.
• Risk Management: Proven ability to identify, assess, and mitigate project risks effectively.

Responsibilities:

• Manage various project services including Project Management, Project Engineering, Project Facilities Support, Project Quality Engineering, Plant Commissioning, Project Administration, Project Documentation Management, and CAD Services.
• Serve as the primary point of contact between client and the Project Execution Team.
• Oversee resource identification, onboarding, training, performance, and other HR-related issues.
• Ensure project staffing requirements are met and manage turnover if necessary.
• Own construction turnover to F&E, CQV, and Ops Readiness teams.
• Manage schedules for Pre-CQV Activities, including Equipment Readiness (Procurement, Receipt, Installation, Integration, Certifications, Calibration, CQV handoff, Transfer of Care Custody and Control).
• Oversee Commissioning Delivery for non-critical systems (facility and grey utilities).
• Manage Transfer of Care Custody and Control.
• Coordinate internal building impact and impairment.
• Manage Engineering Documentation (Registration Drawings, Facility and Utility Drawings, ETOPs, Lifecycle documents such as Impact Assessments and Sensor Risk Assessments).
• Own project work order generation, execution, closure, and process management.