POSITION OVERVIEW

Senior-level process engineer with specialized fill/finish expertise to lead sterile drug product manufacturing facility projects for pharmaceutical, biotechnology, animal health, and ATMP sectors. Role encompasses design through construction documentation, client management, and team leadership.

EDUCATION & EXPERIENCE

• Bachelor’s degree in Chemical, Biochemical, or Mechanical Engineering (Master’s preferred)
• Minimum 10 years biopharmaceutical process engineering experience with significant fill/finish and aseptic processing background
• Experience with A&E consulting firms or pharmaceutical manufacturing preferred
• Proven track record leading design projects from concept to construction

SOFTWARE & PROFESSIONAL SKILLS

• Preferred process simulation, design, and editing software includes: SchedulePro, FlexSim, AutoCAD, Revit, BlueBeam, AFT Fathom, and AFT Arrow
• Professional Engineer (PE) license preferred (or ability to obtain within 2 years)
• Strong project management skills with budget/schedule experience
• Knowledge of FDA, EMA, and ICH guidelines for sterile manufacturing
• Familiarity with ISPE Baseline Guides and GMP requirements
• Experience with PHA, HAZOP studies, and risk assessment methodologies

PHYSICAL AND TRAVEL REQUIREMENTS

• Lift up to 15 pounds, conduct fieldwork, navigate construction sites
• Work in cleanroom environments including Grade A/ISO 5 aseptic areas
• Travel 10-20% for project sites, client meetings, and industry events