Job Title: Validation Engineer
Location: Carlow, Ireland

Overview:
Our client, a leading pharmaceutical company based in Carlow, Ireland, is seeking an experienced Validation Engineer to join their innovative and expanding team. This role offers a fantastic opportunity to work on cutting-edge projects in a state-of-the-art facility, supporting the production of life-changing medicines. The Validation Engineer will be responsible for ensuring all validation activities, including equipment validation and sterilization validation, are completed in compliance with regulatory standards and company protocols. You will work closely with cross-functional teams, contributing to key project milestones and driving quality and compliance in all processes.

Key Responsibilities:
Project Management:

• Lead Suite Teams (six Suite Teams in total), ensuring successful delivery on project scope and objectives.
• Manage scope, budget, risks, and change control, escalating issues as necessary to maintain project momentum.
• Track and monitor project performance, ensuring timely completion of all validation activities.
• Collaborate with Engineering, Construction Management, and Quality teams to ensure alignment on project execution.
• Provide detailed status reports to the Core Team and Project Management on a regular basis.

Validation Responsibilities:

• Provide project validation support, including conducting equipment performance qualifications, with a focus on cleaning and sterilization validation.
• Author and maintain project validation master plans, ensuring all validation activities are well-documented and compliant.
• Develop, author, and review Standard Operating Procedures (SOPs) and other project documentation.
• Lead the preparation and execution of validation protocols and final reports, ensuring accurate and timely analysis of validation data.
• Troubleshoot and resolve technical issues encountered during validation study execution.

Team Coordination and Collaboration:

• Coordinate and align Suite Team activities, focusing on design delivery, documentation, and qualification efforts.
• Provide training and mentorship to Suite Team Leads, promoting continuous improvement within teams.
• Ensure Suite Teams are fully resourced and capable of meeting project demands.
• Resolve cross-functional issues, facilitating strong communication and collaboration across departments.

Performance Monitoring and Compliance:

• Track performance metrics, ensuring validation activities meet project scope, budget, and schedule requirements.
• Collaborate with multiple stakeholders to ensure projects meet business needs and objectives.
• Ensure lessons learned, changes, and impact of changes are captured and shared effectively across the team.
• Work with Technical Leads to ensure all work complies with company procedures and regulatory requirements.
• Lead efforts related to cost management, risk management, change management, and scheduling for the Suite Teams.

Required Skills and Experience:

• Experience leading design, installation, and commissioning projects in a pharmaceutical setting.
• Strong background in equipment validation and sterilization validation, with a deep understanding of industry best practices.
• Proven ability to manage scope, cost, and schedule in high-value pharmaceutical projects.
• Excellent technical writing and oral communication skills, essential for producing high-quality validation documents and reports.
• Ability to work independently and collaboratively within a cross-functional team to meet validation project goals.

Desirable Skills:

• Experience with API project validation is highly advantageous.
• Project Management Certification (such as PMP, Prince2, or equivalent) is preferred.

Why Carlow?
Carlow offers a vibrant community and an exceptional quality of life, with beautiful landscapes and a rich cultural heritage. This thriving town is the perfect location for professionals seeking both career advancement and a high standard of living.

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

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