Manufacturing Project Engineer

Exyte GmbH•Boston, MA

14h

About The Position

Exentec BioPharma Solutions is seeking an experienced 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.

Requirements

A bachelor’s degree in Mechanical Engineering is required.
1–2 years of engineering experience, ideally involving capital equipment.
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.

Nice To Haves

Experience in the pharmaceutical industry is highly preferred.

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.