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Reference Number:
08-02224
Job Description:
RCM Technologies is a leading provider of comprehensive Information Technology and Engineering solutions for customers in the Aerospace, Distribution, Engineering, Financial Services, Government, Healthcare, Insurance, Technology, Manufacturing, Pharmaceutical, Telecom, and Utilities markets and is seeking a:
Position: Senior Validation Engineer
Location: Summit, New Jersey
Duration: 6 months contract to hire
MUST BE US CITIZEN OR GREENCARD HOLDER.
Experience Level:
5+ Years
Requirements:
Responsibilities will include, but are not limited to the following:
Maintain computer systems in compliance with policies, guidelines, and procedures.
Supervise electronic records management.
Assist key customer groups in the operation of application software.
Conduct training of Celgene staff regarding computer validation, electronic records management, and other Quality Assurance topics.
Prepare and execute computer system validation documents.
Perform compliance assessments of computerized systems.
Participate in software vendor audits.
Supervise the daily activities of junior staff and responsible for validation project
management.
Skills/Knowledge Required:
BS or BS/MS degree in Computer Science, Chemistry, Life Sciences or Engineering.
7-10 years experience in Information Technology.
Knowledge of GxP regulations, GAMP, and good documentation practices.
Expertise in analytical laboratory data systems or manufacturing automation.
Knowledge of computer network and system security principles.
Familiarity with 21 CFR 11.
Experience creating and executing computer systems validation documents.
Ability to interact effectively with laboratory, QA, and IT groups.
Preferred Skills/Knowledge:
2 years experience creating SQL + queries under Oracle 8i or newer
2 years experience creating reports using Crystal Reports 10 or newer
2 years experience performing manual/automated testing using tools such as Mercury Quality Center
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