Senior Mechanical Designer

Job Description

Job Description

MR Lowcountry, LLC .

Nebo, NC 28761 Telephone: View phone number on us.fitly.work View email address on us.fitly.work

 

Senior Mechanical Designer Aiken, SC area - Full Time-On-Site

 

Position Summary

The company’s headquartered is in Massachusetts. They produce plant-based ingredients in their manufacturing facility is 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 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 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 detailed 2D and 3D mechanical drawings, models, and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP and cGMP standards.
• Design 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.
• Perform design calculations, tolerance analyses, and material selections appropriate for cleanroom and regulated environments.
• Review and redline vendor drawings; ensure equipment meets functional and regulatory requirements.

 

Project Execution

• Lead mechanical design workstreams on capital projects from initiation through commissioning, qualification (IQ/OQ), and handover.
• Collaborate with process engineers, automation engineers, quality, and facilities to align mechanical designs with operational requirements.
• Support equipment procurement by developing RFQs, evaluating vendor proposals, and participating in FATs/SATs.
• Coordinate with contractors and construction teams during installation; provide field engineering support as needed.
• 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, EU GMP Annex 1 (where applicable), ASME BPE, and other relevant standards.
• Participate in design reviews, HAZOP studies, and risk assessments; document findings and drive closure of action items.
• Support change control, deviation management, and CAPA processes from an engineering design perspective.
• Maintain drawing and document archives in the company engineering document management system (EDMS).

Mentorship & Collaboration

• Provide technical guidance and mentorship to junior and mid-level mechanical designers.
• Contribute to CAD standards, drawing templates, and best-practice documentation for the engineering team.
• Actively participate in cross-functional project teams and present design solutions to stakeholders at all levels.

Qualifications

 

Required

• Bachelor’s degree in Mechanical Engineering, Mechanical Design Technology, or related field
• 7+ years of mechanical design experience, with at least 3 years in a GMP-regulated biotech or pharma environment
• Advanced proficiency in AutoCAD 2D and AutoCAD 3D (AutoCAD Mechanical or Plant 3D experience a plus)
• Demonstrated experience designing process equipment, utility systems, or facility improvements in a manufacturing plant
• Proficiency in engineering calculations, GD&T, and material selection for sanitary/pharmaceutical applications
• Strong written and verbal communication skills; ability to produce clear technical documentation

 

Preferred

Experience with ASME BPE piping standards and hygienic design principles

Familiarity with cleanroom classifications (ISO 5–8) and HVAC/environmental control concepts

Experience with SOLIDWORKS or Inventor as a supplemental tool

Knowledge of CFR 21 Part 11 electronic records requirements

PMP or equivalent project management certification

Lean / Six Sigma Green Belt or equivalent continuous improvement experience

 

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