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Manufacturing Specialist

  • Job reference: 932859
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 23/11/2020

Orion Group are recruiting a Manufacturing Specialist on behalf of our Multinational Pharmaceutical Client based in South Dublin on an initial 19 month contract with potential to be extended.

Manufacturing Specialist

Description:

The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:

  • Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances 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 NC processing are exceeded
  • Assisting as needed in audit by external agencies in answering questions related to NCs
  • Performing other duties as required by Manufacturing Management Basic


    Qualifications:
  • 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)
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
  • 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 Preferred
  • Experience with investigations into manufacturing deviations and determination for product impact potential, root cause, and corrective actions
  • Project Management experience
  • Experience interacting with representatives of regulatory agencies

For a completely confidential chat regarding this position and a number of other potential opportunities please reach out to Callum directly at Callum.Crowe@Orioneng.com

#Recruitment #lifescience #Manufacturing #Engineering


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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