Mechanical Project Engineer
2 weeks ago
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.
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