Senior Process Engineer - Life Sciences
9 days ago
Broomfield
Job DescriptionSenior Process Engineer - Life Sciences (Fill/Finish Specialist) - Broomfield, CO or Lenexa, KSAbout GBA George Butler Associates is a full-service architecture and engineering firm delivering compliant facilities for the biopharma ecosystem, supporting clients through conceptual planning, facility design, equipment procurement, utility engineering, automation design, and commissioning. 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. Key Responsibilities Design & Project Leadership • 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, • 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), • 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, • Lead feasibility studies and process simulations, • Conduct process hazard analysis (PHA) and risk assessments, • Optimize aseptic processing and fill/finish operations, • 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, • 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), • 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, • 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 experiencePhysical 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 eventsCompensation & Benefits, • 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