Senior Mechanical Designer - GMP Biotech Equipment

Cypress HCM; Augusta (GA); On-site; USD 100,000 - 140,000; Full time

Job summary

Cypress HCM is seeking a Senior Mechanical Designer to own the mechanical design and documentation for GMP-regulated biotech/pharma projects from concept through installation.

You will develop 2D/3D drawings in AutoCAD and Plant 3D, design process equipment and utility systems, and produce P&IDs, layouts, and specs for cleanroom environments. Experience in IQ/OQ, FAT/SAT, and CAPA is expected.

Qualifications

• 7+ years of mechanical design experience in GMP-regulated biotech/pharma environments.
• Bachelor's degree in Mechanical Engineering, Mechanical Design Technology, or related field.
• Experience designing process equipment, utility systems, or facility improvements in manufacturing plants.

Responsibilities

• Develop 2D and 3D mechanical drawings, models, and assemblies per GMP standards.
• Design process equipment, piping, utility systems, and facility modifications in biotech/pharma areas.
• Produce and maintain P&IDs, layouts, installation drawings, BOMs, and specs.
• Perform design calculations and material selections for sanitary/pharma applications.
• Lead design workstreams on capital projects through commissioning, IQ/OQ, and handover.
• Support procurement via RFQs, vendor evaluation, FATs/SATs, and field support during installation.
• Ensure designs meet FDA 21 CFR Parts 210/211, EU GMP Annex 1, ASME BPE.
• Participate in design reviews, HAZOPs, risk assessments, and change controls.
• Mentor junior designers and support CAPA/deviation processes.

Skills

GD&T

Engineering calculations

Project leadership

Education

Bachelor's degree in Mechanical Engineering

Tools

AutoCAD 2D/3D

AutoCAD Mechanical

Plant 3D

SOLIDWORKS

Inventor

Job description

Cypress HCM is seeking a Senior Mechanical Designer to own the mechanical design and documentation for GMP-regulated biotech/pharma projects from concept through installation.

You will develop 2D/3D drawings in AutoCAD and Plant 3D, design process equipment and utility systems, and produce P&IDs, layouts, and specs for cleanroom environments. Experience in IQ/OQ, FAT/SAT, and CAPA is expected.