Sr. Mechanical Designer

About The RoleOur client, a growing biotech and pharmaceutical manufacturer, is looking for a Senior Mechanical Designer to own the design and documentation of mechanical systems, equipment, and facilities in a GMP-regulated environment, taking projects from concept through installation. What You'll DoDevelop 2D and 3D mechanical drawings, models, and assemblies in AutoCAD and AutoCAD 3D per GMP/cGMP standardsDesign process equipment, piping, utility systems, and facility modifications for biotech/pharma manufacturing areasProduce and maintain P&IDs, equipment layouts, installation drawings, BOMs, and design specsPerform design calculations and material selections suited to cleanroom and regulated environmentsReview and redline vendor drawingsLead mechanical design workstreams on capital projects through commissioning, qualification (IQ/OQ), and handoverSupport procurement through RFQs, vendor evaluation, and FATs/SATsProvide field engineering support to contractors during installationEnsure designs meet FDA 21 CFR Parts 210/211, EU GMP Annex 1, ASME BPE, and related standardsParticipate in design reviews, HAZOP studies, and risk assessmentsSupport change control, deviation, and CAPA processesMentor junior and mid-level designers RequiredBachelor's degree in Mechanical Engineering, Mechanical Design Technology, or a related field7+ years of mechanical design experience, including 3+ years in a GMP-regulated biotech or pharma environmentAdvanced AutoCAD 2D and 3D (AutoCAD Mechanical or Plant 3D a plus)Experience designing process equipment, utility systems, or facility improvements in a manufacturing plantProficiency in engineering calculations, GD&T, and material selection for sanitary/pharmaceutical applications PreferredASME BPE piping standards and hygienic design experienceFamiliarity with cleanroom classifications (ISO 5-8) and HVAC/environmental controlsSOLIDWORKS or InventorKnowledge of 21 CFR Part 11PMP or equivalentLean / Six Sigma Green Belt or equivalent Work EnvironmentMix of office/CAD work and active manufacturing and lab areas, including cleanrooms (occasional gowning required)Occasional travel to vendor sites for FATsAbility to lift up to 25 lbs and stand/walk on the production floor for extended periods Salary: $100k-140k depending on experience