LSC have a great contract opportunity for a CSA SME to join a leading Global Pharmaceutical company based in Limerick.
Purpose of the Role
The CSA Subject Matter Expert (SME) is a crucial role in our biopharma campus project, responsible for overseeing the construction, installation, and verification of all Civil, Structural, and Architectural elements of pharmaceutical buildings, including cleanrooms. 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.
- Serve as the primary expert in Civil, Structural, and Architectural disciplines for the biopharma campus project, providing guidance and technical insight.
- Manage and oversee the CSA aspects of the construction, installation, and verification processes in pharmaceutical buildings, ensuring compliance with industry standards and specifications.
- Review and approve relevant documentation, including installation records, test protocols, and commissioning reports.
- Ensure that cleanrooms meet the stringent standards and requirements for pharmaceutical manufacturing, including cleanliness, environmental control, and safety.
- Implement and oversee quality control and assurance measures to guarantee the integrity and safety of CSA components.
- Work closely with other project stakeholders, including architects, engineers, contractors, and regulatory bodies, to ensure seamless integration of CSA elements.
Verification and Validation:
- Monitor construction progress, track milestones, and ensure that construction completion dates are met in a timely and cost-effective manner.
- Oversee the verification and validation processes for CSA components, ensuring that they meet regulatory and safety standards.
- Address and resolve any CSA-related issues or discrepancies that may arise during the construction process.
Safety and Compliance:
- Maintain accurate records, reports, and documentation related to CSA activities, compliance, and project progress.
Walk Downs and Handover:
- Uphold safety regulations, industry standards, and all relevant codes in CSA design, construction, and installation.
EDUCATION AND QUALIFICATIONS:
- Participate in walk downs and inspections to ensure that the CSA elements are ready for handover to the end user.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Paul O'Driscoll at +35321 477 7329 if you have any more questions about this opportunity!
- Bachelor's degree in Civil Engineering, Structural Engineering, Architecture, or a related field. Advanced degrees or certifications are a plus.
- Proven experience in CSA project management within the pharmaceutical, biopharma, or similar highly regulated industries.
- Extensive knowledge of clean room design and compliance.
- Strong understanding of regulatory guidelines, such as FDA cGMP, ISPE, and ASTM standards.
- Excellent communication and teamwork skills.
- Problem-solving abilities and attention to detail.
- Familiarity with project management software and tools.
- Knowledge of sustainable and energy-efficient CSA practices is a plus.