* Serve as System Administrator for all Validated Computer Systems on Site Work cooperatively with system owners to ensure CSV compliance, timely and appropriate audit trail reviews, and access and user control.
* QA Review and approval of Equipment and System Validations that have a CSV element
* Reviewing and approving validation protocols and final reports, and ensuring that validation documentation is adequate, correct, and controlled appropriately
* Effectively communicating validation requirements to affected departments within the organization and ensuring that validation is performed in a cGMP compliant manner
* Outstanding client and interdepartmental communication skills
* Thorough understanding of both US and EU validation requirements for facilities, utilities, equipment, and biological processes
Who you are:
* Bachelor's degree in science or IT disciple or 7+ years equivalent experience
* 5+ years' experience in quality and/or validation experience in a GMP environment
* 3+ years' experience with IT or Computerized System Validation
* Experience with MS Word and Excel preferred
* Experience in Quality Control or with Analytical Systems preferred
* Experience in a Systems Administration role with computerized systems experience preferred
Job Requisition ID: 192802
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.