LSC have a requirement for an experienced Biotech Manufacturing Specialist to work on their client site based in Dun Laoghaire, Dublin and to be primarily responsible for resolving fill/finish non-conformances.
As Manufacturing Specialist you will be:
o Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve non-conformances in a timely manner.
o Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA).
o Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded.
o Assisting as needed in audit by external agencies in answering questions related to NCs * Performing other duties as required by Manufacturing Management Basic
As Manufacturing Specialist you will have:
o Bachelor’s Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) or Associate’s Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
o 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
o Detailed technical understanding of fill/finish operations
o Experience participating in and leading cross-functional teams
o Experience in managing multiple, competing priorities in a fast-paced environment
o Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
o Project Management experience
o Experience interacting with representatives of regulatory agencies
For full details on this role please contact Kathy at 021 4777329 or apply directly through this advert.