R&D Partners is seeking to hire a Sr. 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.

R&D Partners is an equal-opportunity employer.