Job Title: Site Validation Specialist
Our client, a leading pharmaceutical company, is seeking an experienced Site Validation Specialist to oversee the commissioning and qualification process at their Clonmel facility.
Key Responsibilities:
1. Manage a team of engineers on high-profile client sites throughout the project lifecycle.
2. Develop and implement Commissioning and Qualification strategies to ensure compliance with GMP and regulatory requirements.
3. Review and approve technical documentation from design phase to ensure alignment with company guidelines and regulations.
4. Investigate and resolve technical issues with assistance from engineers and/or suppliers.
5. Ensure site project execution is undertaken in compliance with company procedures, safety standards, and regulatory requirements.
6. Coordinate Mechanical Completion procedures and Construction scope of work (Walkdown, system acceptance, punch list, and follow-up).
7. Organize and review daily activities of assigned CQV Engineers.
8. Apply project management principles to coordinate CQV activities and reporting to Company and Clients PM.
9. Manage contractors and vendors, ensuring timely completion of tasks and services.
10. Prepare final Handover reports for Client users.
Requirements:
1. Previous experience as a Senior/Lead CQV Engineer.
2. Desirable: Delta-V experience, running EMs and CMs.
3. API experience required.
If you are a skilled Site Validation Specialist looking for a challenging role, contact us today.