Quality Systems Engineer- CSV Specialist

Function as the site SME for Computer Software Validation (CSV), Data Integrity, and GxP computerized systems for Clinton/Devens, providing governance and oversight of the validation lifecycle of regulated software systems. Lead and support software validation projects, perform risk assessments for new systems and periodic reviews for existing systems, and maintain a site inventory list of GxP impacting systems. Collaborate cross-functionally with all departments to develop and improve software systems, including maintaining harmonization with Jabil Global Team.

• Own, develop, and maintain QMS documentation for CSV Process
• Maintain GxP System Inventory which identifies the software used by Clinton/Devens site
• Lead periodic review process – including user access review for software systems used at site
• Coordinate with IT when hardware/software upgrades are needed
• Support and provide guidance to users regarding software validation activities
• Serve as site CSV and Data Integrity SME, providing guidance and support during audits, investigations (CAPA’s), and compliance activities.
• Secondary Owner for QMS/LMS software systems - supporting site administration, maintenance, and adherence to regulatory/customer requirements as applicable
• Author/Review/Approve documents such as User Requirement Specifications, Validation Plans, Risk Assessments, Test Protocols/Reports, Validation Summary reports
• Ensure compliant use of Change Notices for documentation submission/changes
• Participate in problem-solving and process improvement activities
• Support all programs and initiatives related to the Jabil Healthcare Ethics code, Values and Sustainability programs
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position

• Bachelor’s Degree in Engineering, Science – or related discipline preferred
• 1-2 years of software validation experience, preferably in the medical device or pharmaceutical industry but any industry knowledge is acceptable. Knowledge of ISO 13485 and FDA part 820 is preferred

• Excellent attention to detail, follow-through and organizational skills
• Must be self-motivated and able to work independently with minimal supervision/guidance
• Preferred demonstrated working knowledge of CSV practices and requirements in a regulated medical device manufacturing environment (21 CFR Part 820,21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),etc.).