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Chiesi USA, Inc.

Senior Engineering Project Manager

Chiesi USA, Inc.
ParmaPosted 1 weeks ago
Full-timesenior

Job Description

This is what you will do

We are seeking an experienced Senior Engineering Project Manager to lead complex capital and process engineering projects within the pharmaceutical environment. This role is responsible for delivering projects in compliance with GMP requirements, ensuring alignment with regulatory standards, and driving operational excellence across manufacturing and facility initiatives.

You will be responsible for

  • Leading end-to-end execution of medium and large-scale engineering projects (e.g., facility expansions, cleanroom construction, equipment upgrades, process implementation)
  • Defining project scope, timelines, budgets, and resource allocation strategies
  • Ensuring full compliance with GMP (Good Manufacturing Practices), regulatory requirements, and internal quality standards
  • Coordinating cross-functional teams including Engineering, Quality Assurance, Validation, Manufacturing, HSE and Regulatory Affairs
  • Overseeing design, procurement, construction, commissioning, qualification (IQ/OQ/PQ), and handover phases
  • Managing external contractors, EPC partners, and equipment vendors
  • Identifying project risks and implement mitigation and contingency plans
  • Monitoring KPIs, project milestones, and financial performance
  • Leading governance meetings and provide regular updates to senior leadership
  • Driving continuous improvement initiatives and apply best practices in project delivery

You will need to have

  • Bachelor’s degree in engineering (Chemical, Mechanical, Industrial, or related field)
  • 10 - 12+ years of experience in engineering/project management within the pharmaceutical or life sciences industry
  • Strong knowledge of GMP, validation processes, and regulatory frameworks (e.g., FDA, EMA)
  • Proven experience managing capital projects in regulated environments
  • Demonstrated leadership in cross-functional and international teams
  • Excellent communication and stakeholder management skills

We would prefer for you to have

  • Master’s degree or MBA
  • Project Management certification (e.g., PMP, Prince2)
  • Experience with biologics, sterile manufacturing, or API production
  • Familiarity with digital tools (e.g., MES, SAP, project management software)
  • Experience with sustainability or energy optimization projects 

Key Skills

  • Strategic project leadership
  • Regulatory compliance and quality mindset
  • Risk management and problem-solving
  • Budgeting and cost control (CAPEX/OPEX)
  • Vendor and contract management
  • Change management

Location

Parma

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About Chiesi USA, Inc.
501-1000 employees
Cary, North Carolina, US
Senior Engineering Project Manager at Chiesi USA, Inc. | Renata