Senior Mechanical Designer

Position Summary

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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:

• 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

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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 change 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.
• Maintain drawing and document archives in the company engineering document management system (EDMS).

Mentorship \& Collaboration

• Provide technical guidance and mentorship to junior and mid-level mechanical designers.
• Contribute to CAD standards, drawing templates, and best-practice documentation for the engineering team.
• Actively participate in cross-functional project teams and present design solutions to stakeholders at all levels.

Qualifications

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Required

• Bachelor’s degree in Mechanical Engineering, Mechanical Design Technology, or related field
• 7\+ years of mechanical design experience, with at least 3 years in a GMP-regulated biotech or pharma environment
• Advanced proficiency in AutoCAD 2D and AutoCAD 3D (AutoCAD Mechanical or Plant 3D experience a plus)
• Demonstrated 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
• Strong written and verbal communication skills; ability to produce clear technical documentation

Preferred

• Experience with ASME BPE piping standards and hygienic design principles
• Familiarity with cleanroom classifications (ISO 5–8) and HVAC/environmental control concepts
• Experience with SOLIDWORKS or Inventor as a supplemental tool
• Knowledge of CFR 21 Part 11 electronic records requirements
• PMP or equivalent project management certification
• Lean / Six Sigma Green Belt or equivalent continuous improvement experience

Work Environment \& Physical Requirements

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• Work is performed in a combination of office/CAD environment and active manufacturing/lab areas including cleanrooms.
• Occasional gowning required when entering classified manufacturing spaces; adherence to site EHS and GMP protocols is mandatory.
• May require occasional travel to vendor sites for FATs or to other company facilities.
• Ability to lift up to 25 lbs and stand/walk on the production floor for extended periods during project support activities.