Project Engineer

The Project Engineer – Pharmaceutical Plant is responsible for the technical planning, design, and execution of engineering projects that support pharmaceutical manufacturing operations. The Project Engineer coordinates with cross-functional teams to deliver capital improvements, facility upgrades, equipment installations, and process optimization initiatives, ensuring compliance with cGMP, safety, and regulatory requirements.

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• Plan, organize, and manage engineering projects related to pharmaceutical manufacturing facilities, including new equipment installation, facility modifications, process improvements, and utility systems upgrades.
  
• Prepare project scopes, cost estimates, technical specifications, schedules, and resource plans in alignment with business objectives.
  
• Lead or support the design, procurement, installation, commissioning, and qualification (IQ/OQ/PQ) of equipment and systems in compliance with cGMP and safety standards.
  
• Collaborate with manufacturing, quality assurance, validation, EHS, and maintenance teams to ensure seamless project execution and handover.
  
• Coordinate and supervise contractors, vendors, and third-party service providers to ensure project deliverables meet technical and regulatory requirements.
  
• Conduct risk assessments, support root cause analysis, and contribute to problem-solving initiatives.
  
• Maintain comprehensive project documentation, including technical drawings, change controls, validation protocols, and qualification reports.
  
• Manage project budgets, monitor expenses, and track project progress against schedules and milestones.
  
• Support regulatory audits and inspections by ensuring engineering solutions and documentation meet all relevant quality and compliance standards.
  
• Drive continuous improvement efforts in equipment, processes, and engineering practices.
  

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• Bachelor’s degree in Engineering (mechanical, chemical, process, or related discipline).
  
• 2+ years of experience in engineering projects within the pharmaceutical, biotechnology, or regulated manufacturing environment.
  
• Strong technical knowledge of pharmaceutical manufacturing processes, cGMP, and regulatory requirements.
  
• Experience with commissioning, qualification, and validation (CQV) of equipment and utilities is an asset.
  
• Proficient with engineering design tools, project management methodologies, and MS Office Suite.
  
• Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.
  
• Strong analytical, organizational, and communication skills.
  
• Knowledge of health, safety, and environmental regulations. xcfaprz
  
• Ability to work effectively with cross-functional teams and external vendors.