Quality Systems Engineer- CSV Specialist

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.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com 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, driver’s 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 (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) 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.

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 Always_Accessible@Jabil.com 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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