CSV Engineer
CSV Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Lead computer software validation (CSV) project planning activities including the creation or updates to URS SDS and RTM documents.
- Create review and approve software validation documentation.
- Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews.
- Review and approve internal and vendor software packages and test documentation.
- Prioritize and plan all assigned projects for the software validation department.
- Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies procedures and processes for computerized systems.
- Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative.
- Lead the Installation Qualification (IQ) of manufacturing lines.
- Support CSV improvement initiatives in manufacturing.
- Champion crosscollaboration across functions sites and operating companies in the area of CSV.
- Identify and resolve barriers that impede business needs.
- Collaborate with Franchise Quality in the deployment (design implementation and postmonitoring) of Quality System initiatives impacting the site that promote the continuous improvement of the Quality System.
- Ensure continuity of the application of globally shared processes and systems at the site level.
- Support compliance activities by participating in audit readiness support internal and external audits pertaining to CSV.
- Serve as the Subject Matter Expert for CSV and manage investigations responses and remediation of sitespecific CSV audit observations Must have very good written and verbal communication skills.
- Customer support experience preferred.
Requirements:
- Working knowledge of FDA and European medical device regulations (QSR and ISO) is required.
- Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required.
- Working knowledge of GAMP5 and SDLC is required.
- Working knowledge of regulations for electronic records electronic signatures and data integrity is required.
- Experience with change management and a strength with technical writing is required.
- Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations is required.
- Experience in Quality Auditing and notified body inspections is preferred.
- Experience in Quality Systems process development support integration or enhancement is preferred.
- Experience with training or coaching others is preferred.
- A minimum of 4 years of experience in a regulated environment is required.
- CSV SDLC CCB IQ URS SDS and RTM.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
