Senior Pharmaceutical Engineer - Aseptic Processing: Cork
Responsible for contributing to the technical management and oversight of multiple injectable commercial pharmaceutical products, as follows:
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.
Co-ordinates 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 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 prioritisation 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.
Relevant experience in the pharmaceutical industry.