CSV Engineer

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

Travel Required:

Shift:

Duration:

Job Function: