My client, a global biopharmaceutical company based in Co. Cork, is recruiting for a Senior Pharmaceutical Engineer Level 3.
This role would be 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 CAPAs
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 CMOs 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.
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.
Good understanding of/experience with applied statistics and data analysis.
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.
8+ years of experience in the pharmaceutical industry and a BS or BA.
6+ years of relevant experience and a MS.
Must have experience with injectables and solid pharmaceutical
For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671