We are seeking a talented individual to join our Pharmaceutical organization in Carlow. This is an excellent opportunity for anyone who wants to work with a leading multinational company.
Duties include:
* Executing cleaning cycle development and performance qualification of equipment
* Developing and implementing validation strategies, coordinating with external vendors, writing protocols independently, submitting samples, analyzing test results, and preparing technical reports
* Managing business activities such as equipment periodic reviews, cleaning periodic reviews, CAPAs, deviations, change control, risk assessments
* Providing support during commissioning phase by reviewing and approving documents, ensuring documentation meets standards
* Participating in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
* Writing technical reports, performing statistical analysis of data
* Adhering to the latest regulatory guidelines
* Representing the IPT on cross-functional project teams
* Providing technical input and support, presenting as a subject matter expert on relevant topics during regulatory inspections
* Ensuring compliance with site EHS policy, cGMP, and other business regulations, supporting Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations
* Ensuring highest Quality, Compliance, and Safety standards by participating in and complying with our Manufacturing Division Quality Management System (QMS) requirements
Education and Experience:
* Experience as a validation specialist in a pharmaceutical or highly regulated environment, with a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field
* Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering
* A working knowledge of GxP systems associated with this role, including GLIMS and eVAL, electronic batch records