Validation Engineer

Validation Engineer

Manpower has an exciting opportunity for a Validation Engineer with our Life Sciences client based in Waterford.

About the opportunity.
As a Validation Engineer you will be responsible for commissioning, qualification and validation activities for sterile filling line complying with Engineering and Validation lifecycle requirements including but not limited to FAT, SAT, DR, IV, OV, IQ, OQ and PQ activities for 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. The following activities will be included as part of your role:

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 Validation plans as required for the projects
• Write qualification/validation protocols, execute protocols and author reports. Resolve protocol non-conformances as per site procedure.
• 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

Requirements

• Bachelor's degree in engineering/science and >5 years of relevant experience (e.g., engineering or quality role in a regulated environment, preferably GMP)
• Strong interpersonal, organizational and technical skills. Capability to work both independently and in a team environment. Strong analytical and communication skills are required
• Experience in Commissioning, Qualification and Validation

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
• Understanding of Validation using risk-based approach