Mechanical Project Engineer

Roles and Responsibilities

• Lead mechanical engineering projects from conceptualization to commissioning, ensuring timely completion within budget and quality standards.
  
• Collaborate with cross-functional teams to develop project plans, schedules, and budgets for green field projects.
  
• Conduct site visits to monitor progress, identify issues, and implement corrective actions as needed.
  
• Ensure compliance with safety regulations, industry standards, and company policies throughout the project lifecycle.
  
• Develop detailed designs for mechanical systems using CAD software such as AutoCAD or SolidWorks.
  

Desired Candidate Profile

• 7 to 10 Experience in an API plant technical engineering skills and quality/compliance management. 
• Proven experience in the design, specification, and procurement of mechanical equipment for pharmaceutical use, such as Reactors, ANFD, Centrifuge , RCVD, Micronize ,  heat exchangers, Blower , Vessels, pumps, Hot water system ,Scrubber and Vacuum pump.
• Ability to read, interpret, and develop Piping and Instrumentation Diagrams (P&IDs), mechanical layouts, and material flow diagrams. 
• Extensive experience in authoring and reviewing User Requirement Specifications, which define the functional and operational expectations for new equipment or systems. 
• Experience in preparing detailed BOQs, floating inquiries, performing technical and commercial evaluations, and comparing vendor offers.
• Expertise in developing detailed technical specifications for various equipment and components, ensuring they meet process and regulatory needs. 
• Hands-on experience in URS, DQ, SAT,FAT, IQ,OQ,QRM and GMP Documents ( Change control , deviation and Report  
• Experience in identifying, evaluating, and developing new vendors for equipment and services.
• Thorough knowledge and adherence to international regulatory norms and standards are vital for Pharmaceutical needs.  
• A working knowledge of guidelines from the 

  USFDA

  , 

  WHO

  , 

  MHRA

  , and 

  PMDA

  , and how they apply to engineering projects and validation in an API environment.
• Knowledge of Environmental, Health, and Safety (EHS) policies and regulations.