CSV Systems Engineer, Quality & Compliance

Jabil; Harvard (MA); On-site; USD 65,000 - 104,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, vision insurance

401(k) match

Employee stock purchase plan

Paid time off

Tuition reimbursement

Life and disability insurance

Commuter benefits

Employee assistance program

Pet Insurance

Job summary

Jabil is seeking a site CSV, Data Integrity SME for Clinton/Devens to govern the validation lifecycle of regulated software systems. You will own, develop, and maintain QMS documentation for CSV, maintain GxP system inventory, and lead periodic reviews including user access.

Collaborate cross-functionally with IT and other departments to ensure regulatory compliance and readiness for audits. You should have a Bachelor's in Engineering or Science and 1–2 years of software validation experience,

Qualifications

• Attention to detail and strong organizational skills.
• Self-motivated with ability to work independently.
• Experience with CSV practices and regulatory environments preferred.

Responsibilities

• Own, develop, and maintain QMS documentation for CSV Process.
• Maintain GxP System Inventory identifying software used at the Clinton/Devens site.
• Lead periodic reviews including user access review for software systems at site.
• Coordinate with IT for hardware/software upgrades when needed.
• Support and guide users on software validation activities.
• Serve as site CSV and Data Integrity SME during audits and investigations.
• Author/Review/Approve documents like URS, Validation Plans, Risk Assessments, Protocols/Reports.
• Ensure compliant use of Change Notices for documentation submission/changes.
• Participate in problem solving and process improvement activities.
• Support programs related to Jabil Healthcare Ethics, Values and Sustainability.

Skills

Attention to detail

Independent worker

Self-motivated

Regulatory knowledge

Education

Bachelor’s degree in Engineering or Science

Job description

Jabil is seeking a site CSV, Data Integrity SME for Clinton/Devens to govern the validation lifecycle of regulated software systems. You will own, develop, and maintain QMS documentation for CSV, maintain GxP system inventory, and lead periodic reviews including user access.

Collaborate cross-functionally with IT and other departments to ensure regulatory compliance and readiness for audits. You should have a Bachelor's in Engineering or Science and 1–2 years of software validation experience,