As a Validation Engineer you will be responsible for commissioning, qualification and validation activities complying with Engineering and Validation lifecycle requirements including but not limited to FAT, SAT, DR, IV, OV, IQ, OQ and PQ activities for computer systems, facilities, utilities, equipment, cleaning and sterilization. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at the company.
• Responsible for qualification and validation activities.
• Perform qualification and validation activities in a GMP manner aligning with site standards and industry expectations for a sterile manufacturing facility.
• Develop test scripts and execute software tests both automated and manual.
• Develop Validation plans as required for the projects.
• Write qualification/validation protocols, execute protocols and author reports. Resolve protocol non-conformances as per site procedures.
• Knowledge of company standards and industry practices is a requirement.
• Present validation approach and study results to project peers and managers.
• Present and defend validation studies during regulatory inspections and internal audit.
• Generate deviations, CAPAs, perform investigations and root cause analysis.
• Perform change control assessments.
• Perform SOP revision, review and approval.
• Complete all internal and external training.
• Bachelor’s degree in engineering/science and 5 years of relevant experience (e.g., engineering or quality role in a regulated environment, preferably GMP.)
• Experience in Commissioning, qualification and Validation.
• Excellent written and verbal presentation skills to support interactions with senior leadership and inspectors are required.
• Strong interpersonal, organizational and technical skills.
• Capability to work both independently and in a team environment.
• Strong analytical and communication skills are required.
• Excellent understanding of Software Development Life Cycle (SDLC.)
• Preferred Qualifications:
• Familiarity with applicable HPRA, US and EU regulatory requirements.
• Excellent technical writing and verbal communication skills.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio
• Knowledge of Validation Lifecycle Approach.
• Must be able to establish strong working relationships with stakeholders and other departments.
• Understanding of Validation using risk-based approach.
• Demonstrated success working across organizations in highly cross-functional team environment.
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