Quality Systems Engineer- CSV Specialist

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

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

How will you make an impact?

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.

What will you do?

• 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.

How will you get here?

• Experience: 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

Knowledge/Skills Required:

• 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.).
• *This position is not eligible for immigration and/or visa sponsorship. Applicants must be legally authorized to work in the United States without current or future sponsorship by Jabil. Applicants requiring sponsorship will not be considered.

BENEFITS PACKAGE WITH JABIL

• Competitive base salary
• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&DJBL TA - Job Requisition Process Status, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunity

The pay range for this role is $64,700 - $103,500. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [e-mail] or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

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