GBA Companies
Senior Process Engineer - Life Sciences
GBA Companies, Broomfield, Colorado, United States, 80020
Current job opportunities are posted here as they become available.
Senior Process Engineer - Life Sciences (Fill/Finish Specialist) - Broomfield, CO or Lenexa, KS
About 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
Lead design work and prepare construction drawings/contract documents 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 Fill/Finish Technical Expertise 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) Client Engagement & Business Development 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 Technical Leadership & Risk Management 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 Required Qualifications
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 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) 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 Leadership & Communication 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 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 Salary:
$120,000 - $170,000 annually plus performance bonus Professional development budget, conference attendance, leadership programs Clear advancement pathway and mentorship opportunities GBA is an equal opportunity employer. Benefits subject to change per company policy.
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About 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
Lead design work and prepare construction drawings/contract documents 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 Fill/Finish Technical Expertise 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) Client Engagement & Business Development 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 Technical Leadership & Risk Management 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 Required Qualifications
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 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) 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 Leadership & Communication 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 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 Salary:
$120,000 - $170,000 annually plus performance bonus Professional development budget, conference attendance, leadership programs Clear advancement pathway and mentorship opportunities GBA is an equal opportunity employer. Benefits subject to change per company policy.
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