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, perform equipment sizing 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, interface with equipment vendors, support equipment validation activities.
Client Engagement & Business Development : Serve in design or project management capacity with client contact functions, participate in process discovery workshops, lead field investigations and prepare technical reports.
Technical Leadership & Risk Management : Lead feasibility studies and process simulations, conduct process hazard analysis and risk assessments, optimize aseptic processing and fill/finish operations, mentor junior engineers.
Required Qualifications :
Education & Experience : Bachelor's degree in Chemical, Biochemical, or Mechanical Engineering, minimum 10 years biopharmaceutical process engineering experience with significant fill/finish and aseptic processing background.
Technical Competencies : Expert knowledge of aseptic processing principles and sterile drug product manufacturing, hands-on experience with fill/finish equipment design, specification, and qualification, facility design expertise including cleanroom classification and environmental controls.
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.
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.
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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