Senior Process Engineer - Life Sciences
Senior Process Engineer - Life Sciences
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$ 120000 - 170000
1 Vacancy
Job Description
Senior Process Engineer - Life Sciences (Fill/Finish Specialist) - Broomfield CO or Lenexa KS
About 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
- Bachelors degree in Chemical Biochemical or Mechanical Engineering (Masters 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: $120000 - $170000 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.
Required Experience:
Senior IC
Employment Type
Full-Time
