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:
· Aseptic Process Engineers and Aseptic 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.
· BS or MS in a relevant engineering or science field, or equivalent experience
· Excellent oral and written communication skills in English
· 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
Aseptic Process Engineering Experience:
· Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of:
o cGMP manufacturing process activities within isolators or biosafety cabinets (e.g. Cell and Gene Therapy)
o Sterile Operations - Vial/prefilled syringe/cartridge filling lines
o Lyophilization/freeze drying
o Automated visual inspection systems
o Automated formulation systems
Other Desired Experience:
· Commissioning and Qualification
o Developing Validation / Verification 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 tracability 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