Senior Mechanical Designer

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.

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.

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).

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.

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

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