Job Description:

Lead Mechanical Engineer - Lyophilizers Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years. You will be responsible for executing equipment improvement and capital projects in a cGMP setting associated with sterile injectable products.This opportunity will see you be the system owner for filling and Lyophilizer equipment. JOB TITLELead Mechanical Engineer LMELOCATIONUSA Indianapolis Indiana InSALARY$125K - $150k + Bonus ROLEDESCRIPTIONYou will provide technical support for the manufacturing equipment; investigations, continuous process improvements, change controls, and client onboarding.Provide engineering leadership for technical projects; equipment specification and procurement, process development, drawing development, protocol development, validation input, and terpret, modify and create engineering drawings; Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.Lead and provide technical support for technical investigations. REQUIREMENTSDegree in Engineering related fieldMinimum 10 years' experience in GMPIn-depth knowledge of aseptic manufacturing processesSignificant experience working with Lyophilizers and fill linesRecent experience working on large scale pharma projects ABOUT i-PHARM CONSULTINGi-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. TO APPLYIf you would like to discuss this vacancy further, please call Principal Recruitment Consultant David Fearnley on (718) 514 9604, or email . If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market. KEY WORDSLead Mechanical Engineer Aseptic Quality Engineering QA Engineer USA GMP Quality ISO 9001 Manufacturing Calibration Production Lyophilizers Fill Line Engineer Layouts Isometrics Building Technical Projects Processes change controls Desired Skills and ExperienceDegree in Engineering related fieldMinimum 10 years' experience in GMPIn-depth knowledge of aseptic manufacturing processesSignificant experience working with Lyophilizers and fill linesRecent experience working on large scale Pharma projects