Senior Process Engineer

2 weeks ago

Broomfield, CO, United States Gahagan & Bryant Associates Inc Full time
Job: Senior Process Engineer - Life Sciences (Fill/Finish Specialist)
Location: Broomfield, CO | Lenexa, KS | Lynwood, WA | Remote
Build Your Future with 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.

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 Do
  • Lead design efforts and prepare construction drawings and contract documents
  • Develop process design documentation including PFDs, P&IDs, piping layouts, and equipment specifications
  • Perform equipment sizing, mass/energy balances, and engineering calculations
  • Manage capital projects from concept through commissioning and qualification
  • Lead cross-disciplinary teams and delegate tasks to junior engineers
  • Provide 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 systems
  • Interface with equipment vendors and support validation activities (IQ, OQ, PQ)
  • Engage with clients through workshops, field investigations, and technical documentation
  • Support marketing efforts and proposal development
  • Conduct feasibility studies, process simulations, and risk assessments
  • Mentor junior engineers and contribute to professional development initiatives
What You Bring
  • Bachelor'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 processing
  • Experience with A&E consulting or pharmaceutical manufacturing preferred
  • Proven leadership in design projects from concept to construction
  • Expertise 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 Arrow
  • PE license preferred or ability to obtain within 2 years
  • Knowledge of FDA, EMA, ICH guidelines, ISPE Baseline Guides, and GMP requirements
  • Experience with PHA, HAZOP, and risk assessment methodologies
  • Excellent communication, problem-solving, and leadership skills
Physical Requirements
  • Ability to lift up to 15 pounds
  • Conduct fieldwork and navigate active construction sites
  • Work in cleanroom environments including Grade A/ISO 5 aseptic areas
Travel
This position requires 10-20% travel to project sites, client meetings, and industry events.
Why You'll Love Working Here
  • Competitive salary: $120,000 - $170,000 annually + performance bonus
  • Medical, dental, and vision insurance
  • Life, accident, and disability coverage
  • 401(k) with company match
  • Employee Assistance Program (EAP) and wellness initiatives
  • Paid company holidays, floating holidays, and flexible time off
  • Professional development budget, conference attendance, and leadership programs
  • Clear advancement pathway and mentorship opportunities
Join Our Team
If 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.

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