LSC have a great contract opportunity for a Project Engineer to join a Cork/Dublin based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have 2+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
Key Responsibilities:
- Deliver approved change-management packages for new-site introduction, including change requests, impact assessments, and implementation documentation.
- Develop and coordinate sampling and testing strategies for development and GMP campaigns, ensuring alignment with all relevant stakeholders.
- Prepare material-readiness packages, including availability assessments, shipment schedules, and traceability documentation.
- Establish and manage issue, deviation, and risk resolution processes throughout campaign execution.
- Coordinate the logistical shipment of materials from CDMOs to clinical sites, ensuring compliance and traceability.
- Generate comprehensive project reports, closeout documents, and milestone updates to track progress and ensure deliverables meet the required quality standards.
Required Skills:
- Bachelor's degree in engineering, life sciences, or a related discipline.
- Proven experience in drug-product development, manufacturing, quality, or external manufacturing environments.
- Practical knowledge of delivering change controls and supporting deviation resolution in a GxP setting.
- Experience in developing sampling plans and coordinating external manufacturing activities with CDMOs.
- Proficiency in completing ERP transactions supporting manufacturing and inventory traceability.
- Strong ability to deliver cross-functional project outcomes through clear milestone management and documentation.
Preferred Education and Experience:
- Degree in Engineering, Life Sciences, or a closely related field.
- Prior experience working on early-stage drug development programs.
- Hands-on experience with GMP manufacturing campaigns, change management, and deviation resolution.
- Familiarity with external manufacturing workflows, supply chain coordination, and ERP systems.
Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Apply via this advert or contact Brian Garvey on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
