Senior Pharmaceutical Engineer III - Aseptic Processing
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.