Senior Mechanical Designer

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 changing 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.

• 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

• 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.