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Senior Pharmaceutical Engineer

Engineering
Cork
Claire McGuckin
Permanent
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Job Reference: JO-2006-65229_1591878075

Summary:

Responsibilities



  • Responsible for contributing to the technical management and oversight of multiple 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 internal and 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.

    • 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.

    • Experience with Injectables

    • 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) and working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).

    • 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.

    • 8+ years of experience in the pharmaceutical industry





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Claire McGuckin
Claire McGuckin
Business Unit Lead
Quality & Laboratory
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