We are seeking an experienced CSV Validation Engineer who will play a pivotal role in leading validation strategies for major capital projects.
This is a 12 month hourly rate contract position.
Key Responsibilities
- Write, review and execute Validation Protocols and Reports (for Equipment, software /automation, and enterprise software systems) ensuring compliance to all relevant global and local quality and validation procedures/standards.
- Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc) to ensure equipment /software meets current GMP requirements and industry standards.
- Review change controls and assess impact of changes that affect validated systems and define validation requirements.
- Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
- Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
- Completion of risk assessments, closure of corrective and preventive actions.
- Generation and review of CSV project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
Education / Experience
- Degree in Computer Science, Engineering, Life Sciences, or equivalent.
- Minimum of 4 years CSV /CSA Validation experience with hands-on knowledge of execution of Validation.
- Experience in validation of MES /EBR/LIMS and other enterprise systems (SAAS /cloud-based systems).
- Experience with automated equipment (SCADA/BMS / DCS).
- At least 2 years of Equipment qualification experience (GAMP, Equipment life cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ) Experience with performing data integrity assessments and data mapping.
- Strong interpersonal skills for interacting with other departments.
- Experience within aseptic manufacturing environment.
