Senior Pharmaceutical Engineer

ICDS RECRUITMENT

CORK

Senior Pharmaceutical Engineer - Cork. In this role you will be responsible for contributing to the technical management and oversight of multiple commercial pharmaceutical products, in line with the following: Oversee and contribute 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. Lead 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. Lead technical investigations and assessment of deviations and CAPA’s. Define requirements for, and review, master batch records. Co-ordinate equipment/process qualification (IQ/OQ/PQ) and execute process validation (PV). Write, review and/or approve qualification/validation/technical reports. Responsible for the development, distribution, updating and maintenance of the technical database for all CMO’s currently used by the company 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. Prepare documents for regulatory filings, and review filings, including sections from other disciplines. Responsible for the technical review of pertinent CMC sections of global regulatory filings. Manage complex processes across functions and interact effectively with the other team members to ensure product meets regulatory, performance, and cost requirements. Provide technical guidance and training to junior group members. Interested applicants should have: Degree or Masters in Engineering or Science field, preferably in Chemical Engineering, Pharmaceutical Sciences/Engineering or Mechanical Engineering. A motivated individual, who can work independently, with effective planning and prioritisation skills. Excellent analytical/ problem solving skills. Good understanding of and 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, organisational, 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. You should have at least 6 to 8 years' experience in the pharmaceutical industry, plus a Degree or Master's qualification.

1423 days ago