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Senior Pharmaceutical Engineer III (Injectables)

Reference:KS/AKXG-614333 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a leading Biopharma with significant manufacturing operations in Cork. They are seeking a motivated Senior Pharmaceutical Engineer/ Process Scientist to manage oversight of a number of commercial Pharmaceutical products. The ideal person shall have solids experience as well as a minimum of 6+ years injectables experience. This role is based in Cork & comes with a generous remuneration package. Experience in managing CMOs is desirable also.


  • Responsible for contributing to the technical management and oversight of multiple commercial pharmaceutical products
  • 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 our client 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:

  • BSc 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) 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 and a BS or BA.
  • 6+ years of relevant experience and a MS.
  • Travel: 20-30%

For further details please contact Karen Shiel on 087 7452487 for a confidential discussion or send CV to