Process Engineer

i-Pharm GxP; Illinois; On-site; USD 110,000 - 150,000; Full time

Job summary

i-Pharm GxP is seeking an experienced Process/Mechanical Engineer to support a major GMP biologics capital project focused on SMB chromatography systems. The role involves design oversight from Basic to Startup, with on-site work and a 12‑month contract.

Requirements include 7–10+ years in pharma capital projects, genuine SMB chromatography experience, and strong communication skills to coordinate with cross-functional teams and vendors.

Qualifications

• 7–10+ years' experience on pharmaceutical or biopharmaceutical capital projects.
• Genuine SMB chromatography experience required.
• Strong downstream biologics knowledge.
• Experience from Basic Design through Startup on large projects.
• Owner's Representative or Lead Engineer experience is a plus.
• Excellent communication and stakeholder management.

Responsibilities

• Review and challenge SMB chromatography system designs across the project lifecycle.
• Ensure designs meet GMP, maintenance, and project requirements.
• Review P&IDs, URSs, specifications, vendor docs and equipment packages.
• Provide technical oversight during Basic Design, Detailed Design, Procurement, FAT, Commissioning, Startup.
• Collaborate with cross functional teams to resolve issues and drive decisions.
• Support design reviews, risk assessments, and vendor interactions.
• Act as the owner's technical representative throughout execution.

Job description

Process / Mechanical Engineer – iGAC / SMB Chromatography

Large-Scale Biologics Manufacturing Capital Project

Contract: 12-Month Contract | Onsite | W2 | 4-Year Programme

We are supporting a major GMP biologics manufacturing expansion and are seeking an experienced Process or Mechanical Engineer to support the design and early execution phases of a large-scale capital project, focused on Simulated Moving Bed (SMB) / iGAC chromatography systems. This is a specialist role, separate from the general Bulk team.

Key Responsibilities

• Review and challenge engineering designs across SMB chromatography systems throughout the project lifecycle.
• Ensure equipment and system designs meet operational, maintenance, GMP, and project requirements.
• Review P&IDs, URSs, engineering specifications, vendor documentation, and equipment packages.
• Provide technical oversight during Basic Design, Detailed Design, Procurement, FAT, Commissioning, and Startup.
• Work closely with cross-functional stakeholders to resolve technical issues and drive engineering decisions.
• Support design reviews, risk assessments, and vendor interactions.
• Act as the owner's technical representative throughout project execution.

Required Experience

• 7–10+ years' experience supporting pharmaceutical or biopharmaceutical capital projects.
• Genuine Simulated Moving Bed (SMB) chromatography experience (required differentiator).
• Strong downstream biologics knowledge.
• Proven experience supporting projects from Basic Design through Detailed Design, Procurement, FAT, Commissioning, and Startup.
• Previous experience as an Owner's Representative, Equipment/System Owner, or Lead Process/Mechanical Engineer.
• Strong understanding of P&IDs, URSs, engineering specifications, equipment packages, and vendor documentation.
• Experience reviewing EPCM contractor deliverables and providing technical challenges.
• Excellent communication and stakeholder management skills.
• Willingness to work onsite as project activities increase.

Preferred Technical Experience

• Direct experience with one or more of the following:
• Simulated Moving Bed (SMB) chromatography
• Continuous chromatography
• Downstream purification systems
• Design review and technical oversight of SMB systems

If you have genuine SMB chromatography experience and are looking for your next long-term contract opportunity, we'd like to hear from you.