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Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Senior Manufacturing Specialist


Reference:RH/A008952 Location: Dublin South
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Senior Manufacturing Specialist required for a contract role with a Dublin based Biopharmaceutical facility.


Essential Duties and Responsibilities may include, but are not limited to, the following:

  • The manufacturing specialist will be primarily responsible for resolving fill/finish deviations.
  • Working closely with Quality, Engineering, Process Development, Validation, Manufacturing, Inspection and Packaging to resolve deviations in a timely manner
  • Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
  • Assuring appropriate escalation to various levels of management when timeline requirements for deviation processing are exceeded
  • Assisting as needed in audit by external agencies in answering questions related to deviations
  • Performing other duties as required by Manufacturing Management


Education and Experience:
  • 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)
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
  • Project Management experience
  • Experience interacting with representatives of regulatory agencies
  • Detailed technical understanding of fill/finish operations
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong technical writing and presentation skills
  • Ability to be flexible and manage change
  • Ability to communicate and collaborate with technical and management staff


For more information contactRuth Hollandon087 7822 198or[email protected]