Educational requirements: Bachelor
English requirements: Competent English
Requirements for skilled employment experience for years: 3-5 years
Required residence status: Temporary visa, Permanent resident, Citizen
Accept remote work: unacceptable
Position Overview: The Computer Systems Validation Engineer will be responsible for developing and executing the Computerized System Validation (CSV) deliverables for control systems within Execution Systems (ES) and interfaces.
Main Responsibilities and Accountabilities: • Design, modify, develop, write, review, and implement all Computer System Validation (CSV) documents, protocols, and reports for validation and qualification work. Typical validation deliverables include Validation Plans, System Risk Assessments, Traceability Matrices, Qualification protocols, and Validation Reports. • Execute all Execution Systems IQ and OQ protocols in coordination with Technical SMEs. Generate and track protocol discrepancy reports to closure. • Coordinates all CSV activities by constant communication with affected departments; oversees and reviews validation area processes and procedures; Review and approve computer system change controls, discrepancies, CAPAs • Ensures cGMP/Regulatory compliance with internal/external policies and, guidelines, including internal SOP’s, departmental standards and conventions. • Participate in the execution of gap assessment and remediation activities for the Data Integrity initiatives within CSL manufacturing sites • Participate in assessing system reviews, deviations, CAPA, Changes, continuous improvement, and troubleshooting related to Execution Systems. • Coordinate CSV/SDLC training and education to Execution Systems teams
Requirements/Experience: • 7+ years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and food industries. • Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk-based approach. • Experience with Automation and MES projects and computer validation methodologies. • Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ) • Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc. • Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5, S88. • Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems • Understanding of business and manufacturing logistics and processes. • Proven ability to work within and contribute to a high performing team. • Self-motivated, demonstrates initiative, propensity to drive change • Detail oriented, with strong written and verbal communication skills
