About the Company
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.
About the Role
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.
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.
Qualifications
- Bachelor's Degree (BS) with an emphasis in Engineering/Sciences or equivalent.
- A minimum of 5 years relevant CSV experience, preferably in the life science, pharma, or medical device industry.
- Direct experience implementing CSV activities to support GxP systems.
- Strong knowledge of FDA and cGMP regulations and documentation practices.
- Strong knowledge of 21 CFR Part 11. Strong knowledge of computer system validation methodologies.
- Understanding of modern and risk-based validation executions.
- Ability to work both independently and cross-functionally with IT, QA, and stakeholders in a dynamic, ever-changing environment. Experience qualifying and auditing external vendors.
Equal Opportunity Statement
As an Equal Opportunity Employer, all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, genetic information or protected veteran status and will not be discriminated against on the basis of disability.