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Job Description
We are hiring a Pharmaceutical Technology Specialist II to join our team at our Westport site in Co. Mayo.
This role is responsible for the execution of biologics drug product batches at scale in support of commercial biologics manufacturing and process development.
You will also be responsible for development studies and continuous process improvement initiatives.
This is an exciting opportunity to develop your skills further in operations.
With an exciting pipeline of products and a great salary and benefits package, this may be the ideal opportunity to develop your career with an industry leader.
Responsibilities:
* Manufacture pharmaceutical products
* Support batch preparation activities
* Perform compounding, sterile filtration and filling activities
* Accurately complete documentation on time, accurately and legibly
* Keep the Manufacturing area tidy and clean
* Comply with Good Manufacturing Practices (GMP) and with Standard Operating Procedures (SOPs)
* Set-up, clean and maintain equipment
* Transfer of waste material out of the cleanroom areas
* Work with various vendors on the development/improvement of new and existing systems regarding single use technologies
* Review and contribute to technical documents, including protocols, reports and batch manufacturing documents
* Adhere and support all EHS standard procedures and policies
* Active contribution of functional area continuous improvement initiatives
Qualifications
To succeed in this role, you will have the following education and experience:
* 3rd level qualification in a relevant discipline
* 18-24 months minimum experience in the pharmaceutical or medical device industry
* Prior knowledge of aseptic practices in clean room environments
* Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing and validation is desirable
* Understanding of autoclave sterilization, depryogenation, and filter integrity testing is desirable
* Knowledge of lyophilization and freeze dryer operations is desirable
* Experience with single use technologies is desirable
* Experience working with SAP within a similar industry is preferable
* Experience working in project and team-based environments is essential
* Strong communication, documentation, and IT skills
* Pro-active approach with proven problem-solving skills is desirable