Responsibilities:

• Manage contractors and equipment vendors to ensure all aspects of the projects are completed to specification, on schedule and according to budget.
• Manage changes to project scope ensuring original objectives are met in the appropriate timing.
• Identify and control project risks using appropriate risk management tools and engagement in contingency planning.
• Develop, manage, and maintain up-to-date Project Timelines inclusive of all critical milestones, key interdependencies, and resource constraints, applying appropriate project scheduling techniques.
• Prepare project estimates for design, equipment, installation, labor, materials, and other related costs.
• Coordinate closely with project stakeholders to effectively and efficiently communicate project logistics, impacts to site operations, delivery updates, risks, and solutions.
• Work with clients to source, review, and approve bid packages and proposals.
• Manage and oversee project contract work. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations.
• Ensure compliance with site and OSHA safety standards by reviewing JHA document and monitoring work to ensure the site
• Provide project management reports and presentations. Regularly communicate project status, including challenges and opportunities.

Qualifications and Education:

• Bachelor’s degree in Chemical, Mechanical or other related Engineering or relevant field.
• Minimum of 2-10 years of project engineering experience in a Biopharmaceutical or Pharmaceutical manufacturing facility.
• Previous experience managing capital projects in excess of $100k dollars is preferred.
• Expert knowledge of Project Management methodologies and life cycle including ISPE good practice is preferred.
• Strong understanding of industrial and cGMP requirements, Engineering Life Cycle and associated quality systems.
• Experience facilitating meetings and establishing safe practices in a cGMP environment.
• Solid engineering capabilities related to reviewing and approving construction designs, equipment installation and specifications.
• Knowledge of electrical, mechanical, and environmental engineering, HVAC systems, and utilities.
• Knowledge of commissioning, qualification and validation and other regulatory compliance requirements.