What are the responsibilities and job description for the Computer System Validation (CSV) Engineer position at Regenesis Biomedical?
EOE Statement
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Description
POSITION SUMMARY
Regenesis is seeking an experienced Computerized Systems Validation (CSV) Engineer to oversee and perform CVS activities ensuring that business processes required to operate are qualified and maintained in a validated state according to company directives and procedures. The successful candidate will have advanced knowledge and experience developing and leading CSV and life-cycle management activities to support GxP conforming systems, facilities, and manufacturing. The CSV Engineer understands industry-wide and regulatory expectations for CSV and works with members of IT, QA, and stakeholders to ensure that CSV packages are consistent with validation plans and standard operating procedures and utilizes industry experience to identify continuous improvement opportunities for CSV practices. This position will also support other areas of the Regulatory Affairs & Quality Assurance department such as auditing, supplier qualification, CAPA, and additional tasks determined by management.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment.
- Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards.
- Implementation of qualification / validation requirements for new and existing computer systems.
- Support development and implementation of IT procedures that adhere to Data Integrity requirements as defined in applicable regulation for Raw-Data-Handling systems and solutions.
- Oversee and perform CSV activities and ensures the approach and execution aligns to applicable regulations and Regenesis' directives and procedures.
- Develop / improve and implement CSV documentation such as VPs, Test Scripts, Risk Assessments, Reports, SOPs, Policies.
- Support the implementation and adoption of the corporate CSV program and remediation.
- Support data integrity implementation within CSV program.
- Participate in audits and continuous improvement efforts related to CSV program.
- Qualify software, infrastructure vendors.
- Perform internal and external audits.
- Support the CAPA process.
- Participate in FDA inspections and 3rd party audits.
- Other such duties as determined by management.
Position Requirements
QUALIFICATIONS
WORKING CONDITIONS -PHYSICAL POSITION REQUIREMENTS
Location
Regenesis Biomedical Inc
Full-Time / Part-Time
Full-Time
Exempt / Non-Exempt
Exempt
This position is currently accepting applications.
