Bachelor's degree in Mechanical Engineering required.
1-2 years of engineering experience, preferably with capital equipment.
Experience in the pharmaceutical industry is highly preferred.
Ability to review and approve mechanical engineering project documents.
Knowledge of FDA, GMP, ASME, BPE, and CE regulations.
Proficiency in AutoCAD for drafting and creating P&IDs.
Strong computer skills, including MS Office 365 and SharePoint.
Responsibilities
Define, engineer, specify, plan, and manage mechanical activities for projects.
Support manufacturing and qualification to meet mechanical requirements.
Perform mechanical analyses of filtration and chromatography systems.
Specify components based on customer needs while controlling costs and schedules.
Plan and execute system power-up activities with electricians.
Interface with customers and project teams to communicate needs and expectations.
Support sales efforts by defining specifications and project scope.
Benefits
Opportunity to work in a dynamic and innovative environment.
Engagement with cutting-edge technologies in the pharmaceutical sector.
Collaboration with experienced professionals in a supportive team.
Potential for career growth within a specialized field.
Full Job Description
Discover your exciting role
Exentec BioPharma Solutions is seeking an experienced Lead Manufacturing Project Engineer in Lawrence, MA, to work closely with the operations teams on custom TFF, chromatography, and related hardware systems. This role serves as a key technical resource, evaluating customer specifications and translating them into mechanical designs that comply with ASME, BPE, FDA, and other applicable standards.
Explore your tasks and responsibilities
Define, engineer, specify, plan, and manage all mechanical activities related to assigned projects.
Support manufacturing and qualification activities to ensure mechanical requirements are met.
Perform mechanical analyses of filtration and chromatography systems.
Specify components based on customer requirements while maintaining cost and schedule controls within project scope.
Plan, organize, and execute system power-up activities in coordination with staff electricians.
Interface effectively with customers and internal project teams to communicate needs, expectations, and capabilities.
Support sales efforts, including customer visits, to help define specifications and project scope.
Evaluate quote requests, assess feasibility, and prepare quotations according to established procedures.
Identify required tools and resources to support quotation and project activities.
Maintain familiarity with European and U.S. codes and standards (ASME, BPE, XP, ATEX, CE, etc.).
Seek and evaluate new tools, components, or technologies that improve design efficiency.
Provide consistent communication and feedback to project teams, manufacturing, and customers.
Other duties as assigned.
Show your expertise
A bachelor's degree in Mechanical Engineering is required.
1-2 years of engineering experience, ideally involving capital equipment.
Experience in the pharmaceutical industry is highly preferred.
Ability to review and approve project documents related to mechanical engineering deliverables.
Knowledge of FDA, GMP, ASME, BPE, and CE regulations and guidelines, with the ability to apply them appropriately.
Proficiency in AutoCAD for drafting parts and creating P&IDs.
Ability to stay current with internal and external technologies relevant to Exentec's systems.
Experience in a manufacturing environment, preferably within the biotechnology or pharmaceutical industry.
Strong computer skills, including MS Office 365, Project, SharePoint, and AutoCAD.
Contact:
You want to be part of the Exyte team? We look forward to receiving your application! For further questions and information, please do not hesitate to contact Clinton Crellin via E-Mail at [redacted].
Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.
About Exyte
Exyte is a global leader in design, engineering and construction delivering high-tech facilities, plants and factories. With a history of more than 100 years, the company has developed a unique expertise in controlled and regulated environments. Exyte has a truly global footprint, serving the most technically demanding clients in markets such as semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. The company offers a full range of services from consulting to the managing of turnkey solutions ? delivered to the highest quality and safety standards. Headquartered in Stuttgart, Germany, Exyte employs around 5,700 highly experienced and motivated people.
