Mechanical Designer

Mechanical Designer Aiken, SC Area - Full Time-On-Site The company's headquarters is in Massachusetts. They produce plant-based ingredients in their manufacturing facility using a variety of patented and proprietary microbial technologies. Our specialty products are in the field of food ingredients, flavors and fragrances, agricultural chemicals, and pharmaceuticals. 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 for the Company: Opportunity – To be part in building a company focused on a future increasingly reliant on bio-manufacturing and making a sustainable and positive impact in the world. Accountability – You will build, manage and work in a hands-on environment to develop and articulate the company's product value propositions. Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on bringing cutting edge technologies to market. Key Responsibilities: Design & Engineering Develop 2D and 3D mechanical drawings, models, and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standards. Assist in the design of 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. Support design calculations, tolerance analyses, and material selections appropriate for cleanroom and regulated environments. Review vendor drawings under guidance from senior staff; help verify equipment meets functional and regulatory requirements. Project Execution Support mechanical design workstreams on capital projects from initiation through commissioning and qualification (IQ/OQ). Collaborate with process engineers, automation engineers, quality, and facilities to ensure mechanical designs align with operational requirements. Assist with equipment procurement activities including RFQ preparation and participation in FATs/SATs. Coordinate with contractors and construction teams during installation; provide field support as directed. Track design deliverables, manage drawing revisions, and maintain controlled document packages in accordance with change control procedures. Compliance & Quality Ensure all mechanical designs adhere to FDA 21 CFR Part 210/211, ASME BPE, and other relevant standards under guidance from senior staff. Participate in design reviews and risk assessments; document findings and follow up on assigned action items. Support change control and deviation management processes from an engineering design perspective. Maintain drawing and document archives in the company engineering document management system (EDMS). Collaboration Work closely with senior designers and engineers to develop technical skills and understanding of GMP design principles. Follow established CAD standards, drawing templates, and best-practice documentation for the engineering team. Participate actively in cross-functional project teams and communicate design status to team members and stakeholders. Qualifications Required Associate's or Bachelor's degree in Mechanical Engineering Technology, Mechanical Design, or related field 2–5 years of mechanical design experience; entry-level candidates with strong internship or co-op experience will be considered Proficiency in AutoCAD 2D and AutoCAD 3D; ability to produce accurate, complete design packages independently Basic understanding of GMP requirements and design documentation practices in a regulated environment Working knowledge of GD&T, engineering calculations, and material selection Strong attention to detail and ability to manage multiple drawing deliverables concurrently Preferred Experience in a GMP-regulated biotech or pharmaceutical manufacturing environment Familiarity with ASME BPE piping standards and hygienic design principles Exposure to cleanroom classifications (ISO 5–8) and HVAC/environmental control concepts Experience with SOLIDWORKS or Inventor as a supplemental tool Familiarity with engineering document management systems (EDMS) Lean / continuous improvement mindset or coursework 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. Other Duties Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this job position, and may be added or changed without notice. All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability. Management Recruiters of Lowcountry