Senior Process Support Engineer

The Fountain Group; North Chicago (IL); On-site; USD 95,000 - 145,000; Full time

Job summary

The Fountain Group is seeking an experienced technology transfer lead to support a new product/site transfer project in Illinois. The role will spend 80-90% of time on this product and act as the technical lead across transfer activities, validation strategy, gap assessments, documentation, and cross-functional programs.

Candidates should have 5+ years in GMP/regulatory manufacturing with technology transfer experience; sterile/aseptic background is a plus.

Qualifications

• 5+ years of relevant experience in GMP/regulatory manufacturing.
• Technology transfer experience across sites is required or highly preferred.
• Strong understanding of validation strategies and documentation practices.

Responsibilities

• Serve as the technical lead on product/site transfers, validation strategy, and gap assessments.
• Coordinate cross-functional activities and ensure compliant documentation and protocols.
• Support transfer projects from initiation through execution in a regulated environment.

Skills

GMP experience

Technology transfer

Sterile manufacturing

Validation knowledge

Technical documentation

Cross-functional collaboration

Problem solving

Job description

This role is supporting a new product/site transfer project that is just kicking off. The person will spend roughly 80-90% of their time supporting this one product and will serve as a technical lead across the transfer, validation strategy, gap assessments, documentation, and cross-functional activities.

Looking for candidates with technology/product transfer experience, preferably someone who has supported multiple GMP site-to-site transfers. Will also consider someone with lighter transfer experience if they have a really strong sterile/aseptic manufacturing background.

Must Haves

• 5+ years of relevant experience
• Strong GMP / regulated manufacturing background
• Technology/product transfer OR very strong sterile/aseptic manufacturing experience
• Process validation knowledge/experience
• Experience with technical documentation, gap assessments, protocols/reports, validation strategy, etc.
• Must understand working within a regulated manufacturing environment
• Strong critical thinking and ability to work across cross-functional teams

Nice to Haves

• Pharma sterile/aseptic drug product manufacturing
• Multiple site-to-site technology transfers
• Combination of tech transfer + aseptic manufacturing + validation
• Experience acting as the technical lead on transfer/validation projects
• Experience identifying manufacturing/process efficiencies or cost improvements

Relocation / Travel

• YES — they will consider non-local candidates who are willing to relocate at their own expense.
• Michael does not anticipate much, if any, travel for the role. There is a slight possibility of travel, but it should be minimal.