Job Description
This job function includes but is not limited to:
The CSV Engineer is responsible for authoring, reviewing, and approving computerized system validation documentation to support implementation and change control activities related to GxP software at Agilent. This individual may also support related quality processes to ensure compliance for the IT systems (e.g. CAPA).
Organizational: Reporting to the CSV Manager in the Data Systems Quality (DSQ) organization. No direct reports.
Span of control and authority
- Authority to approve or reject documents or actions within workflows in Agile PLM
- Authority to approve or reject change requests in SAP Solution Manager ChaRM system
- Authority to approve or reject activities related to ensuring compliance to relevant standards and regulations
Communication/Contacts:
Internal:
- Communicate within the Data Systems Quality department, Global Quality and Regulatory Affairs, and the broader Agilent organization (e.g. IT, program management) as appropriate in relation to activities related to the job function.
External:
- External communications in relation to job-related activities (e.g. vendors, external consultants).
2. Job Responsibilities:
- Responsible for authoring, reviewing and approving IT system/software validation documents and change orders.
- Participating in quality compliance activities and projects as related to QMS computerized systems and software. Contribute to process improvement initiatives within Data Systems Quality (e.g. continuous improvement).
- Harmonizing and optimizing systems and processes within the QMS when related to job functions.
- Participating as QA representative in IT projects.
- Driving changes to existing IT QMS processes and technical procedures.
- Developing and/or improving CSV Process training material,
- Provide limited support for internal and external quality audits and inspections as appropriate within scope of duties.
- Be a liaison between DSQ CSV Team and the broader Agilent organization. Drive cross-functional stakeholder collaboration and information sharing across the project team.
Qualifications
1. Education:
- Bachelors or Masters degree in IT, Engineering or other Scientific discipline
2. Experience:
Required:
- A minimum of 4 years computer system validation (CSV) work experience, preferably in a QA function.
- A minimum of 3 years CSV work in the medical device/in-vitro diagnostics or pharmaceutical industry is preferred
- Experience in authoring and review of requirement specifications (e.g. user requirements, functional requirements, technical requirements)
- Experience in validation of computerized systems/IT systems, preferably in a regulated environment
- Demonstrably fluent in English, oral and written. Experience with global teams where common language is English preferred.
- Thoroughly versed in Quality System Standards and Regulations, e.g. ISO 13485, FDA CFR 21 Part 820, 21 CFR Part 11, including preferably IVD/Medical Device legislation in EU (MEDDEV) and USA (MDR).
- Working knowledge of quality system methodology
- Good planning, communication and behavioral skills.
- Training skills
- Demonstrate ability to collaborate across different functions.
- Ability to work under limited supervision. Capable of working independently and the ability to contribute actively in teamwork
- Ability to take global project meetings in IST evenings
Preferred:
- Experience in Agile PLM, SAP ERP, SAP CRM systems a plus but not required
- Experience in Jira a plus but not required
- Experience training others a plus but not required
Additional Details
This job has a full time weekly schedule.
Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory
Top Skills
What We Do
Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us.
Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management.
Customers trust Agilent for solutions that enable insights...for a better world.
