Senior Process Engineer - Life Sciences - 6MeGI6qSbawv-6411

at GBA in Lenexa, Kansas, United States

Job Description

• Lead design work and prepare construction drawings/contract documents
• Generate process design documents (PFDs, P&IDs, piping layouts, equipment specifications)
• Perform equipment sizing, mass/energy balances, and engineering calculations
• Manage capital projects from concept through commissioning and qualification
• Delegate tasks to junior engineers and lead cross-disciplinary teams

• Lead technical evaluations and specifications for critical equipment:
  • Aseptic filling machines (vial, syringe, cartridge, bag systems)
  • Lyophilizers and freeze-drying systems
  • Isolator and RABS technology
  • Capping, sealing, inspection, and packaging equipment
  • Track and trace serialization systems
• Interface with equipment vendors (quotes, bid tabs, selection)
• Support equipment validation activities (IQ, OQ, PQ protocols)

• Serve in design or project management capacity with client contact functions
• Participate in process discovery workshops and define client requirements
• Lead field investigations and prepare technical reports/documentation
• Support marketing activities and develop project scope narratives for proposals

• Lead feasibility studies and process simulations
• Conduct process hazard analysis (PHA) and risk assessments
• Optimize aseptic processing and fill/finish operations
• Mentor junior engineers and maintain professional organization membership

• 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

• Expert knowledge of aseptic processing principles and sterile drug product manufacturing
• Hands-on experience with fill/finish equipment design, specification, and qualification including:
  • Aseptic filling machines (rotary, linear, peristaltic pump, time-pressure systems)
  • Lyophilization equipment and cycle development
  • Isolator/RABS technology and integration
  • Container closure systems and inspection systems
  • Secondary packaging and serialization equipment
• Facility design expertise including:
  • Cleanroom classification and environmental controls (ISO 5/Grade A)
  • Material/personnel flow for aseptic operations
  • Contamination control strategies
  • Utility requirements (WFI, clean steam, compressed air)
• Strong engineering fundamentals (mass/energy balance, equipment sizing, hydraulics)

• 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

• Excellent written/verbal communication with ability to interface with clients, vendors, and teams
• Strong analytical and problem-solving capabilities
• Demonstrated leadership in mentoring junior engineers
• Ability to work independently and manage multiple projects
• Client relationship management and business development experience

• 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

• Salary: $120,000 - $170,000 annually plus performance bonus
• Comprehensive benefits: medical, dental, vision, life insurance, 401(k) matching
• Professional development budget, conference attendance, leadership programs
• Clear advancement pathway and mentorship opportunities