Pharmaceutical Technology Specialist III

Team Horizon is seeking a Pharmaceutical Technology Specialist III for our client’s site in Dublin. The Pharmaceutical Technology Specialist III will specialize in Data Science/Data Analytics and support drug product investigations and product transfers into the Dublin site. This includes but is not limited to leading the continued process verification activities for all commercial products and executing the tech-transfer strategy under the guidance of senior members of the Technical Operations organization.
The position incumbent is also responsible to implement and execute technical life cycle management improvement projects for commercial products based on the trends and findings of the CPV analysis. The Pharmaceutical Technology Specialist III provides high level troubleshooting of existing and new processes, fulfils administrative duties, and generates standard operating procedures for analytics applications, supports technical process investigations with the use of data visualization and statistical techniques, and develops training methods for site personnel.
 

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 

What you will be doing:

• Serve as site representative on technical transfer project teams, ensuring that production concerns and recommendations are factored into early-stage product development in order to optimize manufacturing processes and ensure the site’s ability to consistently supply the new product in the production environment.


• Execute the validation strategy for each new product being transferred or existing product being enhanced, including providing recommendations for batch sizes against forecast and performing and maintaining risk assessments.


• Manage the generation of all production batch procedural documentation, such as project change controls, change notices, risk assessment reports, process validation protocols and reports, new batch manufacturing records.


• Prepare and execute feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing process.


• Support on-site new product development projects and technical lifecycle of marketed products to meet the facility strategic objectives.


• Provide and maintain technical assistance to defined production processes (e.g. increase of plant’s availability, reduction of investment, and production costs, de-bottlenecking, quality improvement etc.)


• The Pharmaceutical Technology Specialist III is responsible for the safe, compliant, and efficient execution of job duties in a team environment.

 

What you need to apply:

• A third level qualification in Chemistry or related Science, preferably a bachelor’s degree.


• 1-3 years related experience and/or training; or equivalent combination of education and experience.


• Experience working with pharmaceutical processing technologies and good understanding of 21CFR / cGMP documentation and electronic systems requirements.


• Demonstrated experience applying sound and critical reasoning to troubleshoot complex process challenges.


• Demonstrated success in making effective and persuasive presentations on complex topics to upper management.


• Proficiency of computer skills with Microsoft Word, Excel, Outlook.


• Functional knowledge with advanced statistical analysis software; Minitab or JMP.


• Technical expertise in the pharmaceutical technology and automated control systems.