Forgot your Password?
Find this page useful? Click
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

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.

Role/Responsibilities:

  • 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 karen.shiel@lifescience.ie