Lead Manufacturing Project Engineer – Biopharma Systems

Exyte; Lawrence (MA); Presencial; USD 90.000 - 150.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Communication

Project coordination

Attention to detail

Regulatory awareness

Educación

Bachelor's degree in Mechanical Engineering

Herramientas

AutoCAD

MS Office 365

Project

SharePoint

Descripción del empleo

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.