Senior Process Engineer - Life Sciences

GBA CompaniesBroomfield, CO, US

30+ days ago

Job type

Full-time

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 systems

Isolator and RABS technology

Capping, sealing, inspection, and packaging equipment

Track and trace serialization systems

Interface 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 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

Technical Competencies

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

Compensation & Benefits

Salary : $120,000 - $170,000 annually plus performance bonus

Comprehensive benefits : medical, dental, vision, life insurance, 401(k) matching

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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Senior Engineer Life • Broomfield, CO, US

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