Mechanical Designer

Why work at

• Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.
• Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.
• Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on the cutting edge.

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 work streams 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.

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 is performed in a combination of office/CAD environment and active manufacturing/lab areas including clean rooms.
• 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.