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Capital Projects Engineer

2 months ago

Melville, New York, United States Kedrion Biopharma Full time

Overview: The Capital Projects Engineer is responsible for overseeing engineering projects at the Kedrion Biopharma facility, focusing on capital initiatives. Experience in refrigeration systems is advantageous.

Key Responsibilities:

  • Develops project concepts and formulates execution plans to align with organizational goals. Conducts cost-benefit analyses to aid leadership in defining project scope and budget.
  • Ensures adherence to environmental, health, safety, and current Good Manufacturing Practices (cGMP) regulations. Maintains compliance with applicable state and federal standards.
  • Offers technical engineering and project management expertise for the design and execution of manufacturing processes, instrumentation, and equipment.
  • Manages the entire project lifecycle, including Project Scope, User Requirements, Conceptual Design, Detailed Design, Installation, Commissioning, Validation, and Operations Handover.
  • Fosters effective collaboration with all departments within the facility.
  • Conducts design studies, engineering test plans, troubleshooting, and coordinates with Quality Assurance, Regulatory Affairs, Safety, Production, Validation, and Maintenance teams.
  • Provides initial design concepts and cost estimates, covering construction, commissioning, and equipment start-up to facilitate project execution.
  • Stays updated on industry advancements and integrates this knowledge into company objectives.
  • Makes autonomous decisions within the defined scope of responsibility.
  • Collaborates closely with all site organizations to ensure compliance with legal and technical standards for project execution.
  • Monitors project costs through detailed financial reporting.
  • Utilizes scheduling tools, such as project management software, to manage timelines effectively.
  • Prepares monthly project status reports, including milestone tracking, risk assessments, and financial updates.

Qualifications and Experience:

  • At least 3 years of experience in the biopharmaceutical, food, or over-the-counter consumer goods sectors in a project engineering capacity. Certifications such as Certified Facility Manager (CFM) or Project Management Professional (PMP) are beneficial.
  • Bachelor's Degree in Engineering is required.
  • Proficient in Microsoft Office Suite, AutoCAD, and Microsoft Project.
  • Familiarity with FDA cGMP regulations, environmental laws, standard operating procedures, quality assurance documentation, equipment validation, specifications, and testing protocols.

Skills and Competencies:

  • Excellent communication and organizational abilities.
  • Proven capability to prioritize and coordinate multiple tasks effectively.
  • Strong project management skills and proficiency with project management tools.
  • Analytical problem-solving skills with a focus on results.