Process and Validation Engineer Lead

Raleigh, North Carolina  /  South Atlantic  /  Full Time

CAI is a 100% employee-owned company established in 1996, that has grown year over year to over 500 employees 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 and Validation Lead
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 Chemical/Mechanical Engineering, or equivalent experience
·         Biologic drug substance 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:
·         10 plus years of experience in designing, operating, installing, troubleshooting, commissioning, and/or qualifying of:
o    Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities
o    Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing
o    Single use biomanufacturing systems
o    Ability to read/understand P&IDs and electrical single line drawings
o    Delta V preferred
o    Continuous Process Verification (CPV) (using Minitab or other statistical software)
o    Process performance qualification (PPQ)
o    Deviation and CAPA investigations
o    Experience with biomanufacturing processes:
§  Cell culture, expansion, harvest, purification, formulation, fill and finish
§  Blood plasma fractionation and component purification
§  AKTA/Chromatography
§  Cell and gene therapy
Other Desired Experience:
·         Commissioning and Qualification
o    Developing Validation Master Plans
o    Performing formal risk assessments / FMEA
o    Identifying Critical Attributes and Critical Process Parameters
o    Developing User Requirements
o    Writing qualification protocols, commissioning plans/test scripts, and summary reports
o    Developing Traceability matrices
·         Project Management
o    Project planning and estimating
o    Schedule development and execution
o    Issue tracking and resolution
o    Establishing metrics and leading team to achieve performance goals
o    Facilitating meetings



  • 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
  • Company Paid Parental Leave
  • No Layoffs in Company History