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.