Manufacturing Project Engineer

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.

• 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 powerup 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.

• 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.

About Exentec BioPharma Solutions
Exentec BioPharma Solutions specializes in customengineered process separation and fluidhandling equipment for the biopharmaceutical industry. Our design, engineering, and project management teams focus on delivering tailored solutions that meet stringent industry and client requirements.

Non-Solicitation
We are not currently accepting third-party agency candidates for this position. Any agency candidate submitted to any employee of Exyte, or its subsidiaries, may be contacted by Exyte, or its subsidiaries, without obligation to the third-party agency.

Employment Sponsorship
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor employment visas at this time.

EEO Statement
Exyte US, Inc. and its subsidiaries are proud to be an Equal Employment Opportunity employer that is committed to supporting an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity), national origin, disability, genetic information, protected veteran status, or any other protected characteristic as outlined by applicable federal, state, or local laws.

You want to be part of the Exyte team? We look forward to receiving your application!

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.