PCI Pharma Services

JOB SUMMARY The CSV Validation Engineer II shall support CSV team in maintaining the systems/software in its most current validated state. Shall ensure that all required Software/System Development Lifecycle Documents are available. Shall be able to generate and execute validation documents including risk assessments, discrepancy management and reports; assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. Have a good understanding and application of regulatory requirements – GxP, Annex 11, ICH Q7A, ASTM E2500 and GAMP JOB DUTIES Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments. Generate and execute validation (IQ, OQ, and PQ) documentation for computer/computerized systems from supporting GxP manufacturing and QC operations and ensure compliance to site procedures and regulatory requirements. Review completed system/software/equipment assessments, user requirements, and specification documents. Support all CSV-required activities under a Change Control and Validation Maintenance of computerized systems. Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance and validation. Ensure appropriate regulatory requirements are addressed in the validation protocols. Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification Author Reports and Trace Matrices for the computerized systems. Perform gap assessments, ensuring compliance is met and maintained. Support system owners and SMEs in addressing identified gaps. Provide support during specification (URS, FS, DDS or CS) document review. Participate in the discrepancy/deviation review and closure. Assess the impact of system changes thru change management; participate in the planning and implementation of change. Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready. Develop and maintain Validation SOPs, forms, documentation and files. PROFESSIONAL SKILLS Excellent written and oral communication to include accurate and legible documentation skills. Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic. Microsoft Office and database management skills.   EXPERIENCE At least 3+ years of relevant computer systems validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments. Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus. EDUCATION Bachelor’s degree in Engineering, Computer Science in related discipline or equivalent. QUALITIES Excellent written and oral communication to include accurate and legible documentation skills. Strong attention to detail. Understanding of group dynamics and teamwork Ability to execute industry best practices and implement these within the framework of existing GAMP regulations.