Job Description
A CSA Subject Matter Expert (SME) is required by CareerWise Recruitment for our multinational biopharmaceutical client in Limerick for a full time onsite, initial 12-month contract role.
The CSA Subject Matter Expert (SME) will play a crucial role, responsible for overseeing the construction, installation, and verification of all Civil, Structural, and Architectural elements of pharmaceutical buildings, including cleanrooms at a new biopharmaceutical site. The CSA SME will also play a pivotal role in monitoring construction completion dates and participating in walk downs for the handover to the end user.
Role of this position
1. Serve as the primary expert in Civil, Structural, and Architectural disciplines for the biopharma campus project, providing guidance and technical insight.
2. Manage and oversee the CSA aspects of the construction, installation, and verification processes in pharmaceutical buildings, ensuring compliance with industry standards and specifications.
3. Review and approve relevant documentation, including installation records, test protocols, and commissioning reports.
4. Ensure that cleanrooms meet the stringent standards and requirements for pharmaceutical manufacturing, including cleanliness, environmental control, and safety.
5. Implement and oversee quality control and assurance measures to guarantee the integrity and safety of CSA components.
JOB REQUIREMENTS
6. Bachelor's degree in Civil Engineering, Structural Engineering, Architecture, or a related field. Advanced degrees or certifications are a plus.
7. Proven experience in CSA project management within the pharmaceutical, biopharma, or similar highly regulated industries.
8. Extensive knowledge of clean room design and compliance.
9. Strong understanding of regulatory guidelines, such as FDA cGMP, ISPE, and ASTM standards.
10. Familiarity with project management software and tools.
11. Knowledge of sustainable and energy-efficient CSA practices is a plus.