Senior Pharmaceutical Engineer III - Aseptic Processing

Senior Pharmaceutical Engineer III - Aseptic Processing

Gilead

Cork, Ireland

Specific Responsibilities for the Position:

Responsible for contributing to the technical management and oversight of multiple injectable commercial pharmaceutical products, in the following ways:

  • Oversees and contributes to the completion of all technical and operational activities related to maintaining commercial product supplies through management of external resources.;Responsible for lifecycle management of commercial products including scale-up, validation, Continued Process Verification and technology transfer between sites to ensure production schedules are met;
  • Technical expertise in parenteral manufacturing areas such as; compounding, aseptic filling, lyophilization, capping, inspection, aseptic practices, sterility assurance studies
  • Leads activities at manufacturing sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for limited-scope projects;
  • Leads technical investigations and assessment of deviations and CAPA’s;
  • Defines requirements for, and reviews master batch records;
  • Coordinates equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes, reviews and/or approves qualification/validation/technical reports.
  • Responsible for the development, distribution, updating and maintenance of the technical database for all CMO’s currently used by Gilead in the manufacturing of commercial products;
  • Responsible for tracking and updating senior management on the routine manufacturing of commercial products providing guidance on potential problems and their resolution;
  • Prepares documents for Regulatory filings, and reviews filings, including sections from other disciplines. Responsible for the technical review of pertinent CMC sections of global regulatory filings;
  • Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements;
  • Provides technical guidance and training to junior group members.

Qualification and Skills Required:

  • BS or MS degree in Engineering or Science field, preferably in Chemical Engineering, Pharmaceutical Sciences/Engineering or Mechanical Engineering;
  • Motivated individual, who can work independently, with effective planning and prioritization skills;
  • Excellent analytical/problem solving skills;
  • Good understanding of/experience with applied statistics and data analysis;
  • Excellent verbal, written, and interpersonal communication skills, with experience writing technical reports;
  • Strong knowledge of Good Manufacturing Practices (GMPs), working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC) and compliance for sterile injectable products manufactured by aseptic processing;
  • Strong computer, organizational, and project management skills required;
  • Ability to function well in small technical groups in a dynamic, fast-paced work environment, working on multiple, time-sensitive projects;
  • Considerable experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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