Senior Process Engineer Life Sciences
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Job Location:
Broomfield, CO - USA
Monthly Salary:
USD 120000 - 170000
Posted on:
22-08-2025
Vacancies:
1 Vacancy
Job Summary
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.
Were 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 Youll 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
- Bachelors degree in Chemical Biochemical or Mechanical Engineering (Masters 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 1020% travel to project sites client meetings and industry events.
Why Youll Love Working Here
- Competitive salary: $120000 $170000 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 youre a motivated engineering professional who takes pride in leading safe high-quality projects wed 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.
Required Experience:
Senior IC
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- Manufacturing
