R&D Partners is seeking to hire aSr. IT Qualification Engineer in Newark, CA.
Your main responsibilities as a Sr. IT Qualification Engineer:
Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts
Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work
Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities
Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts
Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary
What we are looking for in a Sr. IT Qualification Engineer:
Minimum Required: Bachelor's degree in Engineering, Science or related technological field.
Preferred: Bachelor degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS) or any related field.
Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience
Understanding of Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements
Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
Medical insurance - PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Pay Scale:
$120,407- $150,526 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.