Senior Process Support Engineer

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.