Manufacturing Project Engineer (Exentec)

Exyte; Boston (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical solutions company is seeking a Manufacturing Project Engineer to work in Lawrence, MA. This role involves defining and managing mechanical activities for projects while ensuring compliance with FDA and other standards. Candidates should possess a Bachelor's degree in Mechanical Engineering and have 1-2 years of engineering experience, ideally in the pharmaceutical sector. Proficiency in AutoCAD and strong communication skills are key to success in this position.

Qualifications

• 1-2 years of engineering experience, ideally with capital equipment.
• Experience in the pharmaceutical industry is preferred.
• Proficiency in AutoCAD for drafting parts and creating P&IDs.

Responsibilities

• Define, engineer, and manage mechanical activities for projects.
• Support manufacturing to ensure mechanical requirements are met.
• Perform mechanical analyses of filtration and chromatography systems.

Skills

Mechanical Engineering

FDA regulations

GMP knowledge

AutoCAD

MS Office 365

Strong communication skills

Education

Bachelor’s degree in Mechanical Engineering

Tools

AutoCAD

MS Project

SharePoint

Job description

Discover your exciting role

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.

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.

About Exentec BioPharma Solutions

Exentec BioPharma Solutions specializes in custom‑engineered process separation and fluid‑handling 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.

Contact:

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.