Manage the framework, methodology and procedures for computer system validation.
Perform system validation and create validation documentation.
Write and manage the document approval process and resolve deviations.
Perform tests to certify business processes and systems within the validation scope.
Identify, implement and support new IT enabled business capabilities for Quality, Regulatory and EHS.
Master’s degree in Pharmacy, Biology, Engineering, Computer Science, or related field of study plus 1 year of Pharmaceutical, Biotechnology, Biology or related experience. Employer also accepts Bachelor’s degree plus 3 years of experience as an equivalent alternative.
Must have experience or knowledge of:
Pharmaceutical regulations including cGxPs, 21CFR210, 21CFR211, 21CFR11 and Annex 11;
Computer Systems Validation;
Complete validation efforts; and
Willing to travel 10% of the time (domestic)62753BR