Process Development

Manager, Mechanical Design Engineering Product group Direct Hire Massachusetts

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14640 Direct Hire Massachusetts

< Previous Job Back to List Next Job >

Our client is a Fortune 1000 company with broad capabilities in filtration, separation and purification.  They are seeking an experienced Manager with a background in Mechanical Design Engineering to join their growing team in the suburbs of Boston.  

The main function of this role is to lead a small group (5-7) of Process and Mechanical Engineers that owns projects from initial inquiry until customer acceptance and directly manage their own projects.  

Responsibilities include but are not limited to;
•  Review and guide the development of User Requirement Specifications for customers and direct reports.
•  Assist direct reports and customers in the selection of equipment, technologies, and/or designs to meet design requirements. 
•  Ensure design comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
•  Monitor compliance to project scope, schedule and budget relative to the established baseline for projects executed by direct reports.
•  Ensure staff in your group complies with our established quality management system, supplies all technical documentation in accordance to the specification for the project, and executes and coordinates all qualification activities included in the project (pre-Factory Acceptance Testing, Factory Acceptance Testing, and Site Acceptance Testing.
•  Assist customers in their qualification and validation activities if requested.
•  Lead, manage and develop the team members.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BSc/MSc or equivalent in Biochemical engineering, Process engineering, Chemical engineering, Mechanical engineering, or equivalent and expertise in the design, operation, and control of cell culture bioreactors.  Must also have knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment (ASME BPE, GAMP, cGMP, ISPE).  Our client is seeking a minimum 10+ years of experience of process engineering project management of equipment used in Biopharmaceutical manufacturing including large scale and complex projects involving the integration of multiple systems.  Also seeking direct leadership experience in a technical Biopharmaceutical environment and experience in the design and engineering of bioreactors, filtration, separation and capture equipment (direct or tangential flow, filtration, chromatography systems and columns).  Must also have experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry.

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Mechanical Design Engineer/Project Manager (Downstream Equipment) Direct Hire Massachusetts

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14209 Direct Hire Massachusetts

< Previous Job Back to List Next Job >

Our client is a Fortune 1000 company with broad capabilities in filtration, separation and purification.  They are seeking an experienced Mechanical Design Engineer to join their growing team in the suburbs of Boston.  

As a Project Manager, you will serve as technical leader and owner from initial inquiry until customer acceptance.    

Responsibilities include but are not limited to;
•  Define technical process (technology selection, sizing, design testing etc.) and provide technical proposal and costing for the proposed solution.
•  Own the project execution and guide a multidisciplinary team from inception through project completion (establish the project plan, coordinate project team activities, report progress).
•  Control project scope, schedule and budget relative to the established baseline.
•  Establishing functional specification and define and creation of instrument, valve, apparatuses and fitting lists.
•  Ensure design complies with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
•  Execute and coordinate all qualification activities included in the project (pre-Factory Acceptance Testing, Factory Acceptance Testing, and Site Acceptance Testing).
•  Work with outside subcontractors including mechanical fabricators, electronic fabricators, Software designers and automation experts.
  
Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in Mechanical engineering and 5+ years of experience in process engineering / project management of equipment used in Biopharmaceutical manufacturing involving the integration of multiple
systems.  Those with degrees in related fields (Biochemical, Process, or Chemical Engineering) may also be considered.  

Preference given to those with experience in the design and engineering of process equipment for filtration, separation and purification equipment (direct or tangential flow, filtration, chromatography systems and columns etc.) used in a
downstream process and/or experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry. 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs of Boston or able to relocate with very limited assistance.  Approximate travel for this role is not expected to exceed 10% on a
yearly basis.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.