Lead Project Engineer

Exyte; Lawrence (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

Exentec BioPharma Solutions in Lawrence, MA seeks an experienced Lead Manufacturing Project Engineer to translate customer specs into mechanical designs for TFF, chromatography and related hardware, ensuring compliance with ASME, BPE, FDA and other standards.

You will lead mechanical activities, support qualification, perform analyses, specify components, coordinate with electricians, and communicate with customers and internal teams to define scope and deliver quotations.

Qualifications

• Bachelor's degree in Mechanical Engineering required.
• 1–2 years engineering experience, ideally capital equipment.
• Pharma industry experience highly preferred.
• Ability to review and approve mechanical engineering deliverables.
• Knowledge of FDA, GMP, ASME, BPE, CE regulations and guidelines.

Responsibilities

• Define, engineer, plan, and manage mechanical activities for projects.
• Support manufacturing and qualification activities to meet mechanical requirements.
• Perform mechanical analyses of filtration and chromatography systems.
• Specify components per customer requirements while controlling cost and schedule.
• Plan and execute system power-up activities with electricians.
• Interface with customers and internal teams to communicate needs and capabilities.
• Support sales visits to define specifications and project scope.
• Evaluate quotes, assess feasibility, and prepare quotations.
• Identify tools and resources to support quotation and project activities.
• Stay current with ASME, BPE, XP, ATEX, CE standards.
• Seek new tools/technologies to improve design efficiency.
• Provide feedback to project teams, manufacturing, and customers.
• Other duties as assigned.

Skills

Communication

Project coordination

Attention to detail

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Tools

AutoCAD

MS Office 365

Project

SharePoint

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.

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.

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.