Raleigh, North Carolina / South Atlantic / Full Time
CAI is seeking motivated Validation Engineer to support biotech and pharmaceutical projects in Raleigh, Durham, Sanford, Wilson, Rocky Mount, and Greenville, North Carolina.. Relocation assistance is available. These are full-time opportunities with competitive compensation and benefits which include: Long Term Disability and Life Insurance provided by the company. Health insurance at very low cost to employee, 15% retirement contribution, 24 days PTO, 5 sick days per year, and support for continued professional education.
CAI is a 100% employee-owned company providing CQV, start-up, project management and consulting services to FDA regulated and mission critical industries. CAI was established in 1996 and has steadily grown to be an industry leader with 500 employees worldwide.
The Validation Engineer will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.
BS in a Computer Science or Engineering field or equivalent experience (such as the Navy Nuclear Power program, pharmaceutical process engineering, or civilian and military aviation maintenance)
1-6 years' experience with GMP Commissioning and Validation is preferred
Experience with biotech-fermentation, recovery or purification processes and systems is a plus.
Experience with managing a small to medium validation project is a plus
Conversant with MS Word and Excel, especially MS Word Styles and formatting
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
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