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.
RESPONSIBILITIES:
CSA Expertise:
- Serve as the primary expert in Civil, Structural, and Architectural disciplines for the biopharma campus project, providing guidance and technical insight.
Project Oversight:
- 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.
Cleanroom Compliance:
- Ensure that cleanrooms meet the stringent standards and requirements for pharmaceutical manufacturing, including cleanliness, environmental control, and safety.
Quality Assurance:
- Implement and oversee quality control and assurance measures to guarantee the integrity and safety of CSA components.
Collaboration:
- Work closely with other project stakeholders, including architects, engineers, contractors, and regulatory bodies, to ensure seamless integration of CSA elements.
Construction Monitoring:
- Monitor construction progress, track milestones, and ensure that construction completion dates are met in a timely and cost-effective manner.
Verification and Validation:
- Oversee the verification and validation processes for CSA components, ensuring that they meet regulatory and safety standards.
Problem Resolution:
- Address and resolve any CSA-related issues or discrepancies that may arise during the construction process.
Documentation:
- Maintain accurate records, reports, and documentation related to CSA activities, compliance, and project progress.
Safety and Compliance:
- Uphold safety regulations, industry standards, and all relevant codes in CSA design, construction, and installation.
Walk Downs and Handover:
- Participate in walk downs and inspections to ensure that the CSA elements are ready for handover to the end user.
EDUCATION AND QUALIFICATIONS:
- 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.
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!
