LSC have a great contract opportunity for a CSA SME Engineer to join a Limerick based Biotech Drug Substance Manufacturing Facility.
This is an exciting opportunity to work with next-gen manufacturing technologies, advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
If you have at least 5 years of relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or directly at Additionally please contact Cian Marnane at 021 4777 329 if you have any more questions about this opportunity!
