Project Manager

A leading Life Science consultancy company is looking for a Project Manager to join the team in Arizona!

Key Responsibilities

• Capital Project Oversight: Direct and coordinate all phases of capital projects-from initial planning and budgeting through execution and final closeout-ensuring alignment with both site-specific and broader organizational objectives.
• Engineering Leadership: Supervise technical operations related to sterile fill-finish and lyophilization systems, ensuring all activities meet cGMP standards and comply with FDA and global regulatory requirements.
• Process & Equipment Adaptation: Facilitate the design and execution of facility and process upgrades to support new product introductions and client requirements, ensuring effective technology transfer and successful process validation.
• Financial Management: Create and manage detailed project budgets and forecasts; monitor expenditures, identify variances, and uphold fiscal responsibility for capital investments.
• Project Documentation & Governance: Maintain compliance with established documentation standards, phase gate reviews, and change control procedures throughout the lifecycle of technical and operational initiatives.
• Cross-Departmental Coordination: Collaborate with teams across Manufacturing, Quality, Validation, EHS, and Supply Chain to ensure cohesive project delivery and readiness for both clinical and commercial operations.
• Support for Operational Evolution: Play a key role in transitioning the site to a CDMO model by aligning engineering strategies, capacity planning, and infrastructure with client-focused production demands.
• External Partner Management: Oversee third-party engineering firms, equipment suppliers, and contractors to ensure projects meet defined scope, quality, safety, and timeline expectations.

Preferred Skillset

• Education: Bachelor's degree in Engineering, preferably in Mechanical, Chemical, Industrial, or a closely related field. A graduate-level degree is considered an asset.
• Professional Experience: At least 7 to 10 years of hands-on experience in pharmaceutical manufacturing, with a strong emphasis on sterile fill-finish and lyophilization processes. Demonstrated success in managing capital projects, ideally within a contract development or manufacturing organization (CDMO/CMO).
  Experience working with cytotoxic or highly potent compounds is advantageous.
• Technical Proficiency: In-depth knowledge of aseptic manufacturing, freeze-drying technologies, and cleanroom protocols. Understanding of packaging requirements for international markets, including bulk packaging for Japan and full inspection/labeling for U.S. distribution. Familiarity with utility systems and equipment qualification procedures, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ).
• Project & Financial Acumen: Proven ability to lead large-scale capital initiatives, including budget development, financial forecasting, and cost management in regulated environments.
• Interpersonal & Organizational Skills: Effective communicator and leader with the ability to guide cross-functional teams. Highly organized and detail-focused, capable of juggling multiple priorities in a fast-paced setting.

Apply Today!