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 pa

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GBA, Inc

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Senior Process Engineer - Life Sciences