Senior Mechanical Designer - Aiken, SC (Full Time, On‑Site) MR Lowcountry, LLC -

Nebo, NC Contact:

tom@mrlowcountry.com | 843-628-5021 About the Company Our client is a Massachusetts‑based biotech manufacturer producing plant‑based ingredients using patented microbial technologies. Their products support food ingredients, flavors and fragrances, agricultural chemicals, and pharmaceutical applications. Position Overview The Senior Mechanical Designer is responsible for designing, developing, and documenting mechanical systems, equipment, and facility modifications in biotech/pharma manufacturing environments. This role works cross‑functionally from concept through installation, ensuring all designs meet GMP, FDA, and industry standards. Key Responsibilities Design & Engineering Create detailed 2D/3D mechanical drawings and assemblies using AutoCAD and AutoCAD 3D . Design process equipment, piping systems, utilities, and facility improvements for regulated environments. Produce P&IDs , equipment layouts, installation drawings, BOMs, and specifications. Perform engineering calculations, tolerance analysis, and material selection for cleanroom applications. Review/redline vendor drawings and ensure compliance with functional and regulatory requirements. Project Execution Lead mechanical design workstreams for capital projects through commissioning and qualification (IQ/OQ). Collaborate with process, automation, quality, and facilities teams.

Support procurement:

RFQs, vendor evaluations, FAT/SAT participation. Provide field engineering support during installation and construction. Manage drawing revisions and controlled document packages. Compliance & Quality Ensure designs meet

FDA 21 CFR 210/211, EU GMP

Annex 1, ASME BPE, and other standards. Participate in design reviews, HAZOPs, and risk assessments. Support change control, deviations, and CAPA activities. Maintain drawing/document archives in the engineering document management system (EDMS). Mentorship & Collaboration Provide guidance to junior/mid‑level designers. Contribute to CAD standards, templates, and best practices. Present design solutions to cross‑functional stakeholders. Qualifications Required Bachelor's degree in Mechanical Engineering, Mechanical Design Technology, or related field. 7+ years mechanical design experience; 3+ years in GMP‑regulated biotech/pharma. Advanced Auto

CAD 2D/3D

proficiency (Plant 3D or AutoCAD Mechanical a plus). Experience designing process equipment, utilities, or facility improvements. Strong engineering calculations, GD&T, and sanitary/pharma material selection skills. Excellent technical documentation and communication skills. Preferred

ASME BPE

piping and hygienic design experience. Knowledge of cleanroom classifications (ISO 5-8) and HVAC/environmental control. SOLIDWORKS or Inventor experience. Familiarity with CFR 21 Part 11. PMP or Lean/Six Sigma Green Belt. Salas O'Brien Navisworks Work Environment Office/CAD work plus active manufacturing/lab areas including cleanrooms. Gowning required in classified spaces; strict adherence to EHS and GMP protocols. Occasional travel for vendor FATs or other facilities. Ability to lift 25 lbs and stand/walk for extended periods. Equal Opportunity Employer All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, or veteran status. Reasonable accommodations may be provided.

Benefits:

Dental insurance Employee stock ownership plan Health insurance Paid time off Relocation assistance

Work Location:

In person