QA CSV Engineer

CSV Engineer - Pharmaceuticals - 12 Month Contract - Europe

Are you an experienced CSV QA Engineer interested in working for a major EU biotechnology project in Europe? This could be your chance!

Supporting various Computer Systems including SCADA/ PLC OSISoft., OSI PI and MES systems, this individual will support the major project which is entering peak execution phase, managing a range of documentation approval and interface with larger vendor and CQV team.

Based in an easily accessible EU location, this project offers ongoing contract work and the chance to work with an exceptional project team.

Reporting into the Project Quality Lead, this individual will be responsible for acting for Quality on all CSV activities on a complex Drug Substance manufacturing expansion project.

CSV Engineer Reponsibilities:

•  Support validation of the automated/computerised systems to ensure systems are operational, remain validated and appropriate for use by production.
• Systems include Delta V DCS, standalone PLC’s, OSIsoft PI, Infobatch, centralized MES system.
• Review and approval of CSV documentation.
• To provide technical validation support to the Automation team.
• Ensure that qualification activities associated with automated control systems used in manufacturing are performed in accordance with all relevant internal/ external quality and safety standards.
• Support validation activities for Automation/IT Computer Systems team.
• Ensure Data Integrity is considered throughout the validation lifecycle.

About you:

• A solid background in validation of automation and computerised systems is essential.
• Prior experience of representing the Quality function in a CSV capacity on a large-scale project within the pharma/biopharma industry sectors.
• Experience with validation of Business IT Applications/Systems such as MES, or control systems such as DCS, or PLC based control systems.
• Will have a demonstrated track record with relevant experience working in a regulated industry preferably in Pharmaceuticals.
• Previous experience of reviewing and approving CSV/Automation related documentation and supporting vendor-based assessments and testing.
• Good working knowledge of GAMP or other similar guidelines will be highly desirable.
• Automation validation project implementation taking a risk-based approach.
• Able to form effective relationships with key stakeholders, Automation, IT, Engineering, and Operations.

Does this CSV Engineer opportunity sound like a good fit for you? Get in touch with us today to apply.

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website