This position will provide Computer System Validation support throughout IT. Draft and review computer system validation lifecycle documentation (Plans, Requirements, Protocols, Summaries, etc.). Support key validation projects to ensure timely completion and serve as a computer system validation lead on project teams. Ensure that computerized systems are maintained in a manner compliant with corporate and regulatory requirements.
Primary Responsibilities:
· Serving as a member of the Validation oversight department responsible for Enterprise harmonization of LAB sites in support of QC LIMS systems, including re-defining/authoring and assessing all relevant SOP and Policy implementations; ensuring that all validation requirements conform to data integrity standards and compliance in current state and prior to scheduled system releases.
· Managing/assessing validation efforts and drafting/reviewing/approving/executing validation lifecycle documents related to computerized laboratory systems supporting in-process/release testing and enterprise standards.
· Ensuring that validated computerized systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11), as well as maintaining their validated state through periodic system review and effective system administration (user management, data management, preventative maintenance, data integrity objectives.)
· Assist with leveraging/authoring OQ and PQ protocols across sites; execution and writing of test scripts.
· Execute-based system for audits.
· 20% Periodic Reviews and 80% Validation
Qualifications
· 8-10 Years of experience.
· Excellent Computer System Validation Skills
· Should have prior experience as CSV lead.
· Excellent Instrumentation Skills
· Validation experience in a Lab Systems environment.
· A true Lead, able to work independently with little or no guidance.
· Experience with queries and change control systems
· Excellent written and oral communication skills.
· Excellent customer-facing skills.
· Must maintain a working knowledge of cGMP and GxP regulations related to laboratory and database applications.
· Able to think analytically and learn quickly.
· Must have previous experience and knowledge of regulatory requirements related to computer system validation (including 21 CFR Part 11) and 820
· Ability to take initiative, be assertive, and build quality working relationships.
· Bachelor’s Degree.