As a CSV Engineer you will be responsible for CSV assessments, validation, data integrity and 21 CFR Part 11 activities and training. You will ensure that all associated systems and processes perform and operate as per their design intent, and conform to relevant regulatory requirements, as well as company specifications and standards.
This role will be solely focused on Computer Systems Validation (CSV) and Data Integrity (DI) activities associated with our drug filling and device development facilities.
- Maintaining all documentation pertaining to Computer Systems Validation.
- Authoring, reviewing, approving and executing validation protocols, reports, procedures, policies, and masterplans
- Identifying current and future computerized systems validation needs
- Planning and performing routine and project validation work related to meet current GMP regulations and guidelines
- Working with systems owners to ensure validation is conducted prior to deployment of GxP systems
- Be a single point of contact (SPOC) / subject matter expert (SME) for all CSV related queries and issues.
- Ensuring all CSV related control elements are safe, effective, and qualified in compliance with industry standards and regulatory expectations.
- Supporting and leading the processing and managing of associated quality records including assessments, audits, deviations, CAPA’s, investigations.
- Supporting all hardware and software updates and revisions.
- Ensuring that new process systems are included in the plant maintenance and calibration program.
- Participating on project teams through all phases of projects – conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
- Project management of process system upgrades and modifications.
- Understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach.
- Exposure to cGMP regulations related to CSV including CFR 21 Part 11, GAMP 5 and Data Integrity.
- A minimum of 2 years’ experience working within Pharma/Medical/Biotech or similar GMP environment as part of an engineering, technical services, or automation / IT function.
- Knowledge of networking and information transfer systems, such as, SCADA and Enterprise systems.
- Validation experience within automated systems
- Good understanding of general manufacturing activities and automated assembly.
- A postgraduate qualification in Project Management or an Automation, IT or Computer Science discipline would be advantageous.
- Highly motivated individual who is happy working by themselves or in cross functional groups in a relatively flat structure.
- Open, honest, inclusive, personable.
- A team player with good interpersonal and communication skills.
- Able to influence stakeholders to achieve the goals of the company.
- Able to both ‘see the big picture’ and develop robust detail design.
- Willing to travel as required.
If this sounds like you, please send a CV and covering letter to email@example.com with the subject line “CSV Engineer”.