Commissioning and Qualification Specialist

Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company - one that is ready to help create a healthier future for us all.

Technical Specialist Sterile Integrated Process Team (IPT)
*Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes preparing protocols, executing studies, analysing test results, and preparing technical reports.
*Provide technical support to clinical and commercial sterile manufacturing operations as required.
*Assess the technical impact of vendor originated changes and author/approve Change controls as appropriate.
*Represents the department on cross-functional project teams.
*Assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.


Qualifications
*Degree or 3rd level qualification (Science, Engineering, Process)
*Have at least 1-2 years' experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical/Validation role in a manufacturing environment.
*Working knowledge of equipment and systems specifically Autoclave or Cleaning validation an advantage.
*Have Troubleshooting and analytical mind-set with an understanding of regulatory and validation requirements.
*Ability to interact with multiple stakeholders.
*Excellent verbal, written, and interpersonal communication skills are required.

For more information contact justin.pankinas@manpower.ie