Job Description
Job Description
Senior 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
- 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 systemsIsolator and RABS technologyCapping, sealing, inspection, and packaging equipmentTrack and trace serialization systemsInterface with equipment vendors (quotes, bid tabs, selection)Support equipment validation activities (IQ, OQ, PQ protocols)Client Engagement & Business Development
Serve in design or project management capacity with client contact functionsParticipate in process discovery workshops and define client requirementsLead field investigations and prepare technical reports / documentationSupport marketing activities and develop project scope narratives for proposalsTechnical Leadership & Risk Management
Lead feasibility studies and process simulationsConduct process hazard analysis (PHA) and risk assessmentsOptimize aseptic processing and fill / finish operationsMentor junior engineers and maintain professional organization membershipRequired 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 backgroundExperience with A&E consulting firms or pharmaceutical manufacturing preferredProven track record leading design projects from concept to constructionTechnical Competencies
Expert knowledge of aseptic processing principles and sterile drug product manufacturingHands-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 developmentIsolator / RABS technology and integrationContainer closure systems and inspection systemsSecondary packaging and serialization equipmentFacility design expertise including :Cleanroom classification and environmental controls (ISO 5 / Grade A)
Material / personnel flow for aseptic operationsContamination control strategiesUtility 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 ArrowProfessional Engineer (PE) license preferred (or ability to obtain within 2 years)Strong project management skills with budget / schedule experienceKnowledge of FDA, EMA, and ICH guidelines for sterile manufacturingFamiliarity with ISPE Baseline Guides and GMP requirementsExperience with PHA, HAZOP studies, and risk assessment methodologiesLeadership & Communication
Excellent written / verbal communication with ability to interface with clients, vendors, and teamsStrong analytical and problem-solving capabilitiesDemonstrated leadership in mentoring junior engineersAbility to work independently and manage multiple projectsClient relationship management and business development experiencePhysical and Travel Requirements
Lift up to 15 pounds, conduct fieldwork, navigate construction sitesWork in cleanroom environments including Grade A / ISO 5 aseptic areasTravel 10-20% for project sites, client meetings, and industry eventsCompensation & Benefits
Salary : $120,000 - $170,000 annually plus performance bonusComprehensive benefits : medical, dental, vision, life insurance, 401(k) matchingProfessional development budget, conference attendance, leadership programsClear advancement pathway and mentorship opportunitiesGBA is an equal opportunity employer. Benefits subject to change per company policy.
