Mechanical Designer

Position Summary 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 Mechanical Designer supports the design, development, and documentation of mechanical systems, equipment, and facilities used in biotech and pharmaceutical manufacturing environments. Working under the direction of senior engineers and project leads, this role contributes to projects from concept through installation, ensuring designs comply with GMP regulations, FDA guidelines, and applicable industry standards. The ideal candidate brings solid AutoCAD and AutoCAD 3D proficiency, a foundational mechanical background, and an eagerness to grow within a regulated manufacturing setting. Key Responsibilities Design & Engineering Develop 2D and 3D mechanical drawings, models, and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standards. Assist in the design of 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. Support design calculations, tolerance analyses, and material selections appropriate for cleanroom and regulated environments. Review vendor drawings under guidance from senior staff; help verify equipment meets functional and regulatory requirements. Project Execution Support mechanical design workstreams on capital projects from initiation through commissioning and qualification (IQ/OQ). Collaborate with process engineers, automation engineers, quality, and facilities to ensure mechanical designs align with operational requirements. Assist with equipment procurement activities including RFQ preparation and participation in FATs/SATs. Coordinate with contractors and construction teams during installation; provide field support as directed. 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, ASME BPE, and other relevant standards under guidance from senior staff. Participate in design reviews and risk assessments; document findings and follow up on assigned action items. Support change control and deviation management processes from an engineering design perspective. Maintain drawing and document archives in the company engineering document management system (EDMS). Collaboration Work closely with senior designers and engineers to develop technical skills and understanding of GMP design principles. Follow established CAD standards, drawing templates, and best‑practice documentation for the engineering team. Participate actively in cross‑functional project teams and communicate design status to team members and stakeholders. Qualifications Required Associate’s or Bachelor’s degree in Mechanical Engineering Technology, Mechanical Design, or related field 2–5 years of mechanical design experience; entry‑level candidates with strong internship or co‑op experience will be considered Proficiency in AutoCAD 2D and AutoCAD 3D; ability to produce accurate, complete design packages independently Basic understanding of GMP requirements and design documentation practices in a regulated environment Working knowledge of GD&T, engineering calculations, and material selection Strong attention to detail and ability to manage multiple drawing deliverables concurrently Preferred Experience in a GMP‑regulated biotech or pharmaceutical manufacturing environment Familiarity with ASME BPE piping standards and hygienic design principles Exposure to cleanroom classifications (ISO 5–8) and HVAC/environmental control concepts Experience with SOLIDWORKS or Inventor as a supplemental tool Familiarity with engineering document management systems (EDMS) Lean / continuous improvement mindset or coursework Work Environment & Physical Requirements 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. #J-18808-Ljbffr