LSC are looking for a Senior Project CSV Engineer for a Large Scale brown field Biopharmaceutical project in Cork
The CSV Engineer will be responsible for the development and execution of CSV and C&Q deliverables for systems, including automation systems within Biopharmaceutical production facilities. This consists of Validation Planning, User/Functional Requirements, Design Specifications, Design Qualification (DQ), Testing protocols development and execution (software and hardware) and Final Reporting.
Responsibilities will include:
-Development and execution of C&Q and CSV protocols for manufacturing production systems throughout the system development life cycle such as Risk Assessments, Validation/Qualification Plans, User/Functional Requirements, Design Qualification (DQ), FAT/SAT, Testing (IQ/OQ/PQ), Traceability Matrix and Final Reporting on both, legacy systems as remediation efforts and new systems.
-Execution of gap assessments and remediation initiatives regarding data integrity for computerized systems within the site, including laboratory as well as production systems.
Education and Experience:
-Degree in a IT, Science, or Engineering discipline.
-3 to 7 years of related work experience with strong knowledge and hands-on experience of C&Q and CSV activities in the regulated industries.
-Knowledge and experience of API, Bulk Chemicals, Fill Finish, Parenterals, and/or Dry Products processes and technologies.
-Development and execution of C&Q and CSV deliverables for system-development life cycle of industrial automated systems.
-Proficient knowledge of C&Q and CSV system life cycle concepts and FDA regulatory requirements, including FDA cGMP’s for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ISPE C&Q Guidelines 5, 12, ICH 9, ASTM E2500, GAMP5
-Experience with development of Risk Assessments, URS, FRS’s, DDS, DQ, Validation and Test Planning, Development and Execution Commissioning and Qualification protocols.
-Familiarity and exposure with control systems including Delta V, Foxboro, Siemens S7/PCS7 and Rockwell PLC’s, iFIX and Wonderware SCADA system.
Please contact James today to discuss the role further on +353214777329 or apply direct with your up to date CV via this advert. Check out our other vacancies on http://lscconnect.com/jobs/