Job Title: Cleaning Validation Specialist
Cleaning validation specialists play a critical role in ensuring the integrity of pharmaceutical products. As a key member of our team, you will be responsible for validating cleaning cycles and equipment to ensure compliance with regulatory guidelines.
* Develop and execute validation strategies, coordinating with external vendors, creating protocols independently, submitting samples, analyzing test results, and preparing technical reports.
* Execute business activities such as periodic equipment reviews, cleaning validation reviews, CAPAs, deviations, change control, risk assessments, and ensure documentation meets standards.
* Provide support during commissioning phase by reviewing and approving documents and ensuring documentation complies with industry standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Write technical reports, conduct statistical analysis of data, and provide expertise on relevant topics during regulatory inspections.
* Represent the IPT on cross-functional project teams and provide technical input and support.
* Adhere to the highest standards of Compliance (Quality and Safety) and ensure compliance with site EHS policy, cGMP, and other business regulations.
Required Skills and Qualifications:
* Experience as a validation specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or equivalent 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, manufacturing, or process engineering.
* A working knowledge of GxP systems associated with this role would be advantageous, including GLIMS and eVAL, electronic batch records.
Benefits:
This is an exciting opportunity to join a leading multinational in the pharmaceutical industry. As a cleaning validation specialist, you will have the opportunity to work with a talented team of professionals and contribute to the development of cutting-edge products.