Mechanical Designer
The Mechanical Designer at Confidential Client is responsible for developing and documenting mechanical systems and equipment designs for biotech and pharmaceutical manufacturing environments, ensuring compliance with GMP and FDA regulations. This role supports projects from concept through installation, collaborating with engineering and quality teams to deliver precise mechanical designs and maintain rigorous documentation standards in a regulated setting. The position offers growth opportunities within a cutting-edge synthetic biology company focused on sustainable bioalternatives.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Engineering — Biotech & Pharmaceutical Manufacturing.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Why work with Confidential Client
Confidential Client is part of the engineering teams supporting biotech and pharmaceutical manufacturing — focused on delivering high-quality, GMP-compliant equipment and facility designs. This role is a strong opportunity to expand technical skills in AutoCAD 2D/3D while contributing to projects that move lab‑scale innovations into manufacturing.
- Opportunity for career growth in a fast‑moving, mission-driven environment
- Accountability and ownership of deliverables while working with experienced engineering leads
- Collaborative, cross‑functional teams where technical contributions are visible and valued
Key Responsibilities
Design & Engineering
- Develop accurate 2D and 3D mechanical drawings, models, and assemblies using AutoCAD and AutoCAD 3D in compliance with GMP/cGMP standards.
- Assist in the mechanical design of process equipment, piping/utility systems, and facility modifications for regulated manufacturing areas.
- Produce and maintain engineering documentation: P&IDs, equipment layouts, installation drawings, BOMs, and design specifications.
- Support basic design calculations, tolerance analysis, and appropriate material selection for cleanroom and hygienic applications.
- Review vendor drawings and help verify equipment meets functional and regulatory requirements under senior staff guidance.
Project Execution
- Support mechanical design workstreams through capital projects from initiation through commissioning and IQ/OQ support.
- Collaborate with process, automation, quality, and facilities teams to ensure designs meet operational and regulatory needs.
- Assist with procurement tasks including RFQ prep and participation in FATs/SATs.
- Coordinate with contractors and provide field support during installation as directed.
- Manage drawing revisions and controlled documentation consistent with change control procedures.
Compliance & Quality
- Ensure mechanical designs adhere to FDA 21 CFR Part 210/211, ASME BPE, and other applicable standards, following direction from senior engineers.
- Participate in design reviews, risk assessments, and document follow‑up actions.
- Support change control and deviation management from an engineering documentation perspective.
- Maintain drawing and document archives in the engineering document management system.
Qualifications
Required
- Associate’s or Bachelor’s degree in Mechanical Engineering Technology, Mechanical Design, or related field
- 2–5 years of mechanical design experience (strong internship/co‑op experience considered for entry‑level)
- Proficiency with AutoCAD 2D and AutoCAD 3D; able to produce complete design packages
- Basic understanding of GMP requirements and regulated design documentation practices
- Working knowledge of GD&T, engineering calculations, and material selection
- Strong attention to detail and ability to manage multiple deliverables concurrently
Preferred
- Experience in GMP‑regulated biotech or pharmaceutical manufacturing
- Familiarity with ASME BPE and hygienic design principles
- Exposure to cleanroom classifications (ISO 5–8) and HVAC/environmental control concepts
- Experience with SOLIDWORKS or Inventor as supplemental tools
- Familiarity with engineering document management systems (EDMS)
- Lean or continuous improvement experience or coursework
Work Environment & Physical Requirements
- Combination of office/CAD work and time in active manufacturing/lab areas, including classified cleanrooms
- Occasional gowning and strict adherence to site EHS and GMP protocols required
- May involve travel to vendor sites for FATs or to other company facilities
- Ability to lift up to 25 lbs and stand/walk on production floors for extended periods during project support
Compensation & Employment Type
- Salary: USD 100,000 – 120,000 per year
- Employment type: Contract, Full‑time
- Location: Augusta, GA
What We Value
- Clear, concise CAD deliverables and controlled documentation
- Willingness to learn GMP design practices and grow technical depth
- Team‑oriented mindset and proactive communication across stakeholders
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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