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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.

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Must be able to sit or stand for prolonged periods of time
• Must be able to travel between production facilities

COMMUNICATIONS & CONTACTS

• Interacts with all departmental staff and other departments at all levels.

TRAVEL   < 10% or >20%