Job Title: Computer System Validation Lead

Location: Chicago, IL

Duration: 12+ Months

Job Description:

• Above 8+ years experience with Computer System Validation, specifically in the oral solid manufacturing systems and lab systems

• Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)

• Supervision of protocols execution activities

• Excellent communication skills

• Ability to work as a team player in a consulting environment

• Able to manage direct relationships with stakeholders and project team members

• Proactive approach

• English language proficiency

• Valid US work permit

• Full availability to travel (up to 70%) across the US Area and work in the Chicago area.

RESPONSIBILITIES

• Ensure completeness and consistency of validation life cycle documentation for computerized systems used to control/monitor and manage data on laboratory and production environments

• Resolution of fundamental Computer System Validation (CSV) compliance issues derived from the impossible implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems

• Align with eCompliance on project management and life cycle documentation deliverables for GxP relevant projects

• Ensure all project-related risks are well managed and deliverables are validated (for GxP)/tested (for nonGxP) in accordance with SOP and the associated CSV requirements

• Ensure project team complies with the methodology and SOP and uses the correct tools

• Ensure all project-related issues and deviations are recorded, approved, and dispensed accordingly (including ensuring proper deviation report preparation and approval)

• Prepare project and lifecycle reports and review/approve all other documents to ensure compliance with SOP

• Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved in accordance with the prescribed SOP.