Mechanical Designer

Position SummaryManus 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 Why work at ManusOpportunity For motivated results oriented team members our growth creates opportunities for personal and professional advancementAccountability 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 expectationsPassion 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 edgeKey ResponsibilitiesDesign & Engineering Develop 2D and 3D mechanical drawings models and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standardsAssist in the design of process equipment piping systems utility systems and facility modifications for biotechpharma manufacturing areasProduce and maintain engineering documentation including P&IDs equipment layouts installation drawings BOMs and design specificationsSupport design calculations tolerance analyses and material selections appropriate for cleanroom and regulated environmentsReview vendor drawings under guidance from senior staff; help verify equipment meets functional and regulatory requirementsProject Execution Support mechanical design workstreams on capital projects from initiation through commissioning and qualification IQOQCollaborate with process engineers automation engineers quality and facilities to ensure mechanical designs align with operational requirementsAssist with equipment procurement activities including RFQ preparation and participation in FATsSATsCoordinate with contractors and construction teams during installation; provide field support as directedTrack design deliverables manage drawing revisions and maintain controlled document packages in accordance with change control proceduresCompliance & Quality Ensure all mechanical designs adhere to FDA 21 CFR Part 210211 ASME BPE and other relevant standards under guidance from senior staffParticipate in design reviews and risk assessments; document findings and follow up on assigned action itemsSupport change control and deviation management processes from an engineering design perspectiveMaintain drawing and document archives in the company engineering document management system EDMSCollaboration Work closely with senior designers and engineers to develop technical skills and understanding of GMP design principlesFollow established CAD standards drawing templates and best practice documentation for the engineering teamParticipate actively in cross functional project teams and communicate design status to team members and stakeholdersQualificationsRequired Associates or Bachelors degree in Mechanical Engineering Technology Mechanical Design or related field25 years of mechanical design experience; entry level candidates with strong internship or co op experience will be consideredProficiency in AutoCAD 2D and AutoCAD 3D; ability to produce accurate complete design packages independentlyBasic understanding of GMP requirements and design documentation practices in a regulated environmentWorking knowledge of GD&T engineering calculations and material selectionStrong attention to detail and ability to manage multiple drawing deliverables concurrentlyPreferred Experience in a GMP regulated biotech or pharmaceutical manufacturing environmentFamiliarity with ASME BPE piping standards and hygienic design principlesExposure to cleanroom classifications ISO 58 and HVACenvironmental control conceptsExperience with SOLIDWORKS or Inventor as a supplemental toolFamiliarity with engineering document management systems EDMSLean continuous improvement mindset or courseworkWork Environment & Physical RequirementsWork is performed in a combination of officeCAD environment and active manufacturinglab areas including cleanroomsOccasional gowning required when entering classified manufacturing spaces; adherence to site EHS and GMP protocols is mandatoryMay require occasional travel to vendor sites for FATs or to other company facilitiesAbility to lift up to 25 lbs and standwalk on the production floor for extended periods during project support activities