Senior Process Engineer - Life Sciences

Job: Senior Process Engineer – Life Sciences (Fill/Finish Specialist) Location: Broomfield, CO | Lenexa, KS | Lynwood, WA | Remote Build Your Future with GBAGeorge 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.We’re looking for a 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.What You’ll DoLead design efforts and prepare construction drawings and contract documentsDevelop process design documentation including PFDs, P&IDs, piping layouts, and equipment specificationsPerform equipment sizing, mass/energy balances, and engineering calculationsManage capital projects from concept through commissioning and qualificationLead cross-disciplinary teams and delegate tasks to junior engineersProvide technical leadership in fill/finish operations including: Aseptic filling machines (vial, syringe, cartridge, bag systems) Lyophilizers and freeze-drying systems Isolator and RABS technology Capping, sealing, inspection, and packaging equipment Serialization systemsInterface with equipment vendors and support validation activities (IQ, OQ, PQ)Engage with clients through workshops, field investigations, and technical documentationSupport marketing efforts and proposal developmentConduct feasibility studies, process simulations, and risk assessmentsMentor junior engineers and contribute to professional development initiativesWhat You BringBachelor’s degree in Chemical, Biochemical, or Mechanical Engineering (Master’s preferred)10+ years of biopharmaceutical process engineering experience with a strong background in fill/finish and aseptic processingExperience with A&E consulting or pharmaceutical manufacturing preferredProven leadership in design projects from concept to constructionExpertise in: Aseptic processing and sterile drug product manufacturing Fill/finish equipment design, specification, and qualification Cleanroom design and contamination control strategies Utility systems (WFI, clean steam, compressed air)Strong engineering fundamentals and familiarity with tools such as SchedulePro, FlexSim, AutoCAD, Revit, Bluebeam, AFT Fathom, and AFT ArrowPE license preferred or ability to obtain within 2 yearsKnowledge of FDA, EMA, ICH guidelines, ISPE Baseline Guides, and GMP requirementsExperience with PHA, HAZOP, and risk assessment methodologiesExcellent communication, problem-solving, and leadership skillsPhysical RequirementsAbility to lift up to 15 poundsConduct fieldwork and navigate active construction sitesWork in cleanroom environments including Grade A/ISO 5 aseptic areasTravelThis position requires 10–20% travel to project sites, client meetings, and industry events.Why You’ll Love Working HereCompetitive salary: $120,000 – $170,000 annually + performance bonusMedical, dental, and vision insuranceLife, accident, and disability coverage401(k) with company matchEmployee Assistance Program (EAP) and wellness initiativesPaid company holidays, floating holidays, and flexible time offProfessional development budget, conference attendance, and leadership programsClear advancement pathway and mentorship opportunitiesJoin Our TeamIf you’re a motivated engineering professional who takes pride in leading safe, high-quality projects, we’d love to hear from you.Apply today and build your future with GBA.At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.