Senior Mechanical Designer

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 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 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 edgeKey Responsibilities Design & Engineering Develop detailed 2D and 3D mechanical drawings models and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standardsDesign 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 specificationsPerform design calculations tolerance analyses and material selections appropriate for cleanroom and regulated environmentsReview and redline vendor drawings; ensure equipment meets functional and regulatory requirementsProject Execution Lead mechanical design workstreams on capital projects from initiation through commissioning qualification IQOQ and handoverCollaborate with process engineers automation engineers quality and facilities to align mechanical designs with operational requirementsSupport equipment procurement by developing RFQs evaluating vendor proposals and participating in FATsSATsCoordinate with contractors and construction teams during installation; provide field engineering support as neededTrack design deliverables manage drawing revisions and maintain controlled document packages in accordance with changing control proceduresCompliance & Quality Ensure all mechanical designs adhere to FDA 21 CFR Part 210211 EU GMP Annex 1 where applicable ASME BPE and other relevant standardsParticipate in design reviews HAZOP studies and risk assessments; document findings and drive closure of action itemsSupport change control deviation management and CAPA processes from an engineering design perspectiveMaintain drawing and document archives in the company engineering document management system EDMSMentorship & CollaborationProvide technical guidance and mentorship to junior and mid level mechanical designersContribute to CAD standards drawing templates and best practice documentation for the engineering teamActively participate in cross functional project teams and present design solutions to stakeholders at all levelsRequired Qualifications Bachelors degree in Mechanical Engineering Mechanical Design Technology or related field7 years of mechanical design experience with at least 3 years in a GMP regulated biotech or pharma environmentAdvanced proficiency in AutoCAD 2D and AutoCAD 3D AutoCAD Mechanical or Plant 3D experience a plusDemonstrated experience designing process equipment utility systems or facility improvements in a manufacturing plantProficiency in engineering calculations GD&T and material selection for sanitarypharmaceutical applicationsStrong written and verbal communication skills; ability to produce clear technical documentationPreferred Qualifications Experience with ASME BPE piping standards and hygienic design principlesFamiliarity with cleanroom classifications ISO 58 and HVACenvironmental control conceptsExperience with SOLIDWORKS or Inventor as a supplemental toolKnowledge of CFR 21 Part 11 electronic records requirementsPMP or equivalent project management certificationLean Six Sigma Green Belt or equivalent continuous improvement experienceWork Environment & Physical Requirements Work 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