Mechanical Designer

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.

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.

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.

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).

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.

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

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