Bio Manufacturing Process & Validation Engineers

Boston, Massachusetts  /  Process & Manufacturing Technology  /  Full Time


CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries.
 
CAI is seeking motivated biomanufacturing process engineers and biomanufacturing validation engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
 
As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company. 
           
Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.
 
Position Requirements: 
BS or MS in a relevant engineering or science field, or equivalent experience
Excellent oral and written communication skills in English
Team-oriented
Customer-service focused
Able to travel domestically and internationally if required
Able to work (paid) overtime as needed
Able to work in the US without sponsorship now or any time in the future
 
Process Engineering Experience:
Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of:
Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities
Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing
Single use biomanufacturing systems
Continuous Process Verification (CPV) (using Minitab or other statistical software)
Process performance qualification (PPQ)
Deviation and CAPA investigations
Experience with biomanufacturing processes:
Cell culture, expansion, harvest, purification, formulation, fill and finish
Blood plasma fractionation and component purification
Cell and gene therapy  
 
Other Desired Experience:
Commissioning and Qualification
Developing Validation / Verification Master Plans
Performing formal risk assessments / FMEA
Identifying Critical Attributes and Critical Process Parameters
Developing User Requirements
Writing qualification protocols, commissioning plans/test scripts, and summary reports
Developing trace-ability matrices
Project Management
Project planning and estimating
Schedule development and execution
Issue tracking and resolution
Establishing metrics and leading team to achieve performance goals
Facilitating meetings

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CAI BENEFITS

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year
  • Medical / Dental / Vision
  • Professional Development
    (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • No Layoffs in Company History