Senior Mechanical Designer

manusbio; Augusta (GA); On-site; USD 95,000 - 135,000; Full time

Job summary

Manus Bio is seeking a Senior Mechanical Designer in Augusta, GA, full-time, to lead mechanical design efforts for biotech manufacturing facilities. You will develop 2D/3D drawings, define equipment layouts, and ensure documentation complies with GMP and FDA guidelines.

The role requires strong AutoCAD/AutoCAD 3D skills, deep mechanical fundamentals, and a track record in regulated manufacturing. Collaboration with processes, quality, and facilities teams is essential to deliver safe, compliant

Qualifications

• 5+ years of mechanical design in regulated manufacturing environments.
• Proficient with AutoCAD and AutoCAD 3D.
• Experience with GMP/cGMP and regulatory standards.
• Strong documentation skills for drawings, layouts, and specs.

Responsibilities

• Create detailed 2D and 3D mechanical drawings and assemblies using AutoCAD in GMP environments.
• Design process equipment, piping utility systems, and facility modifications for biotech/pharma areas.
• Produce and maintain engineering docs including P&IDs, layouts, BOMs, and specs.
• Perform design calculations, tolerances, and material selections for cleanrooms.
• Review vendor drawings and ensure compliance with requirements.

Skills

AutoCAD

AutoCAD 3D

GMP compliance

Regulatory standards

Tools

P&IDs

Installation drawings

Job description

Senior Mechanical Designer Augusta, Georgia, United States, Full-Time

Manus works across industries and value chains to accelerate the transition to BioAlternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today.

The Senior Mechanical Designer is responsible for the design, development, and documentation of mechanical systems, equipment, and facilities used in biotech and pharmaceutical manufacturing environments. Working within a cross-functional engineering team, this role drives projects from concept through installation, ensuring all designs comply with GMP regulations, FDA guidelines, and applicable industry standards. The ideal candidate brings deep AutoCAD and AutoCAD 3D proficiency, a strong mechanical foundation, and a proven track record in a regulated manufacturing setting.

Why work at Manus Bio:

• Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.
• Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.
• Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on the cutting edge.

Key Responsibilities

Design & Engineering

• Develop detailed 2D and 3D mechanical drawings, models, and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standards.
• Design process equipment, piping systems, utility systems, and facility modifications for biotech/pharma manufacturing areas.
• Produce and maintain engineering documentation including P&IDs, equipment layouts, installation drawings, BOMs, and design specifications.
• Perform design calculations, tolerance analyses, and material selections appropriate for cleanroom and regulated environments.
• Review and redline vendor drawings; ensure equipment meets functional and regulatory requirements.

Project Execution

• Lead mechanical design workstreams on capital projects from initiation through commissioning, qualification (IQ/OQ), and handover.
• Collaborate with process engineers, automation engineers, quality, and facilities to align mechanical designs with operational requirements.
• Support equipment procurement by developing RFQs, evaluating vendor proposals, and participating in FATs/SATs.
• Coordinate with contractors and construction teams during installation; provide field engineering support as needed.
• Track design deliverables, manage drawing revisions, and maintain controlled document packages in accordance with changing control procedures.

Compliance & Quality

• Ensure all mechanical designs adhere to FDA 21 CFR Part 210/211, EU GMP Annex 1 (where applicable), ASME BPE, and other relevant standards.
• Participate in design reviews, HAZOP studies, and risk assessments; document findings and drive closure of action items.
• Support change control, deviation management, and CAPA processes from an engineering design perspective.