Sr. Mechanical Designer

Our client, a growing biotech and pharmaceutical manufacturer, is looking for a Senior Mechanical Designer to own the design and documentation of mechanical systems, equipment, and facilities in a GMP-regulated environment, taking projects from concept through installation.

What You\'ll Do

• Develop 2D and 3D mechanical drawings, models, and assemblies in AutoCAD and AutoCAD 3D per GMP/cGMP standards
• Design process equipment, piping, utility systems, and facility modifications for biotech/pharma manufacturing areas
• Produce and maintain P&IDs, equipment layouts, installation drawings, BOMs, and design specs
• Perform design calculations and material selections suited to cleanroom and regulated environments
• Review and redline vendor drawings
• Lead mechanical design workstreams on capital projects through commissioning, qualification (IQ/OQ), and handover
• Support procurement through RFQs, vendor evaluation, and FATs/SATs
• Provide field engineering support to contractors during installation
• Ensure designs meet FDA 21 CFR Parts 210/211, EU GMP Annex 1, ASME BPE, and related standards
• Participate in design reviews, HAZOP studies, and risk assessments
• Support change control, deviation, and CAPA processes
• Mentor junior and mid-level designers

Required

• Bachelor\'s degree in Mechanical Engineering, Mechanical Design Technology, or a related field
• 7+ years of mechanical design experience, including 3+ years in a GMP-regulated biotech or pharma environment
• Advanced AutoCAD 2D and 3D (AutoCAD Mechanical or Plant 3D a plus)
• Experience designing process equipment, utility systems, or facility improvements in a manufacturing plant
• Proficiency in engineering calculations, GD&T, and material selection for sanitary/pharmaceutical applications

Preferred

• ASME BPE piping standards and hygienic design experience
• Familiarity with cleanroom classifications (ISO 5-8) and HVAC/environmental controls
• SOLIDWORKS or Inventor
• Knowledge of 21 CFR Part 11
• PMP or equivalent
• Lean / Six Sigma Green Belt or equivalent
• Mix of office/CAD work and active manufacturing and lab areas, including cleanrooms (occasional gowning required)
• Occasional travel to vendor sites for FATs
• Ability to lift up to 25 lbs and stand/walk on the production floor for extended periods

Salary: $100k-140k depending on experience