Quality Systems Engineer- CSV Specialist

At Jabil (NYSE: JBL) we are proud to be a trusted partner for the worlds 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 (CAPAs) 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:

• Bachelors 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 82021 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 $64700 - $103500. 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.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number birth certificate financial institution drivers license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft contact the Federal Bureau of Investigations internet crime hotline () the Federal Trade Commission identity theft hotline () and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

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.

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 site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or calling 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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