CSV Engineer

Orion Group Life Sciences are currently recruiting a CSV Engineer on behalf of our Multinational Biopharmaceutical client based in Co. Meath on an initial 11-month contract (with potential to extend).

The successful candidate will Generate/ update, execute, review, and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of Company representatives responsible Process Automation Remediation Plan delivery.

Responsibilities:

• Generate/ update, execute, review, and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery.
• Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
• Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
• Provide technical support for the development of electronic data review procedures
• Actively manage the execution of all CSV testing with right first-time approach.
• Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI's maintained.

Experience, Knowledge, Skills, Education:

• At least 2 years' experience in the planning, document generation, support, or execution of CSV activities in a biologic drug substance manufacturing plant.
• A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
• Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
• Experience in PLC/SCADA/DCS systems
• Bachelor's Degree in Engineering, Information Systems, Computer Science, or the Life Sciences.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.