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Senior Mechanical Designer

Manus Bio

Augusta, GAFull-timeNo compensation foundPosted 3mo agoVerified open 5 days ago
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At a glance

Compensation
No compensation found
Location
Augusta, GA
Schedule
Full-time
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Manus Bio is hiring a Senior Mechanical Designer. The Senior Mechanical Designer at Manus Bio designs, develops, and documents mechanical systems and equipment for biotech and pharmaceutical manufacturing, ensuring compliance with GMP, FDA, and industry standards while collaborating with cross‑functional teams from concept through installation.

Key focus areas include Develop detailed 2D and 3D mechanical drawings, models, and assemblies using AutoCAD, Design process equipment, piping and utility systems, and facility modifications, and Produce and maintain engineering documentation including P&IDs, layouts, and BOMs.

Successful candidates bring Bachelor's Degree In Mechanical Engineering Or Mechanical Design Technology Or Related Field, 7+ Years Mechanical Design Experience, and 3+ Years GMP-Regulated Biotech Or Pharma Experience. Important skills include AutoCAD, GMP Regulations, FDA Guidelines, Mechanical Design, 2D Mechanical Drawings, and 3D Mechanical Drawings. Preferred (not required): Plant 3D, Hygienic Design Principles, Cleanroom Classifications (ISO 5–8), and HVAC/Environmental Control Concepts.

Skills & qualifications

RequiredNice to have

Skills

AutoCADGMP RegulationsFDA GuidelinesMechanical Design2D Mechanical Drawings3D Mechanical DrawingscGMP StandardsProcess Equipment DesignPiping Systems DesignUtility Systems DesignFacility Modifications DesignP&IDsEquipment LayoutsInstallation DrawingsBOMsDesign SpecificationsDesign CalculationsTolerance AnalysesMaterial SelectionsVendor Drawing ReviewProject ManagementCommissioningQualification (IQ/OQ)RFQ DevelopmentVendor Proposal EvaluationFATs/SATsField Engineering SupportDrawing Revisions ManagementChange Control ProceduresFDA 21 CFR Part 210/211EU GMP Annex 1ASME BPEDesign ReviewsHAZOP StudiesRisk AssessmentsDeviation ManagementCAPA ProcessesEngineering Document Management System (EDMS)Technical GuidanceCoachingCAD StandardsDrawing TemplatesBest-Practice DocumentationCross-Functional Project TeamsDesign Solutions PresentationEngineering CalculationsGD&TMaterial Selection for Sanitary/Pharmaceutical ApplicationsCommunicationEngineering DocumentationCleanroom EnvironmentsRegulated EnvironmentsCapital ProjectsEquipment ProcurementRFQsChange ControlCollaborationTechnical DocumentationPlant 3DHygienic Design PrinciplesCleanroom Classifications (ISO 5–8)HVAC/Environmental Control ConceptsSolidWorksInventorCFR 21 Part 11 Electronic Records RequirementsLean / Six Sigma Green BeltMechanical ModelsAssembliesFacility ModificationsPresent Design SolutionsControlled Document PackagesAutoCAD 2DAutoCAD 3DMaterial SelectionBills of MaterialsFATsSATsEDMSAutoCAD MechanicalASME BPE StandardsHVAC ConceptsCFR 21 Part 11 KnowledgeAutoCAD Plant 3DHAZOPCAPACFR 21 Part 11Strong Written CommunicationStrong Verbal CommunicationPMP CertificationHVACLean Six SigmaCommunication SkillsCleanroom Classifications ISO 5–8HVAC and Environmental Control ConceptsCFR 21 Part 11 RequirementsStrong Written and Verbal CommunicationMentorship and Technical GuidanceP&ID DevelopmentRisk AssessmentCleanroom Classification KnowledgeWritten and Verbal CommunicationCFR 21 Part 11 Electronic Records KnowledgePiping System DesignUtility System DesignFacility Modification DesignEquipment Layout DesignInstallation Drawing CreationBill of Materials ManagementDesign Specification DocumentationIQ/OQ KnowledgeFAT/SAT ParticipationDesign Deliverable TrackingDrawing Revision ManagementChange Control DocumentationFDA 21 CFR Part 210/211 KnowledgeEU GMP Annex 1 KnowledgeASME BPE KnowledgeHAZOP StudyAction Item ClosureEDMS ManagementCAD Standards DevelopmentCross-Functional Team ParticipationStakeholder PresentationBill of MaterialsFactory Acceptance TestsSite Acceptance TestsIQ/OQGMP KnowledgecGMP KnowledgeFDA 21 CFR KnowledgeEU GMP KnowledgeASME BPE Piping StandardsProject LeadershipFDA 21 CFR 210/211Cleanroom KnowledgeHVAC KnowledgePMPTechnical Documentation ProductionGMPcGMPISO 5–8 CleanroomASME BPE Standards KnowledgeMechanical FoundationIndustry StandardsDesign & EngineeringDevelop 2D and 3D Mechanical DrawingsDesign Process EquipmentDesign Piping SystemsDesign Utility SystemsDesign Facility ModificationsProduce Engineering DocumentationPerform Design CalculationsReview Vendor DrawingsProject ExecutionLead Mechanical Design WorkstreamsCollaborate With Process EngineersCollaborate With Automation EngineersCollaborate With QualityCollaborate With FacilitiesSupport Equipment ProcurementDevelop RFQsEvaluate Vendor ProposalsParticipate in FATs/SATsCoordinate With ContractorsCoordinate With Construction TeamsProvide Field Engineering SupportTrack Design DeliverablesManage Drawing RevisionsMaintain Controlled Document PackagesCompliance & QualityParticipate in Design ReviewsSupport Change ControlMaintain Drawing and Document ArchivesMentorship & CollaborationProvide Technical GuidanceBOM CreationISO 5–8 Cleanroom ClassificationsCleanroom ClassificationLeanSix Sigma Green Belt2D Mechanical Drawing Development3D Mechanical ModelingBill of Materials CreationMaterial Selection for Sanitary ApplicationsTolerance AnalysisCross‑Functional CollaborationFAT ParticipationSAT ParticipationInstallation CoordinationControlled Document ManagementFDA 21 CFR Part 210/211 ComplianceEU GMP Annex 1 ComplianceASME BPE CompliancePresentation SkillsCleanroom Classification ISO 5–8

Qualifications

Bachelor's Degree in Mechanical Engineering or Mechanical Design Technology or Related Field7+ Years Mechanical Design Experience3+ Years GMP-Regulated Biotech or Pharma ExperienceExperience Designing Process Equipment or Utility Systems or Facility ImprovementsExperience With ASME BPE Piping Standards or Hygienic Design PrinciplesFamiliarity With Cleanroom Classifications ISO 5–8 or HVAC/Environmental Control ConceptsExperience With SOLIDWORKS or InventorKnowledge of CFR 21 Part 11 Electronic Records RequirementsPMP Certification or Equivalent Project Management CertificationLean Six Sigma Green Belt or Equivalent Continuous Improvement Certification

Full 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.

  • 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. Required Qualifications

  • 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 Qualifications

  • 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

  • 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.

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