Job Title
We are seeking a skilled Validation Specialist to join our Pharmaceutical organization in Carlow, Ireland.
Duties and Responsibilities
1. Develop and execute cleaning cycle validation and perform equipment qualification.
2. Write and adhere to validation strategies, coordinate with external vendors, author protocols independently, submit samples, analyze test results, and prepare technical reports.
3. Execute business activities such as periodic equipment reviews, cleaning reviews, CAPAs, deviations, change control, and risk assessments.
4. Provide support during commissioning by reviewing and approving documents, ensuring compliance with standards.
5. Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
6. Prepare technical reports and perform statistical analysis of data.
7. Maintain adherence to the latest regulatory guidelines.
8. Represent the IPT on cross-functional project teams.
9. Provide technical input and support, presenting as an SME on relevant topics during regulatory inspections.
10. Maintain the highest standards for Compliance (Quality and Safety).
11. Ensure compliance with site EHS policy, cGMP, and other business regulations, supporting Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
12. Maintain the highest Quality, Compliance, and Safety standards by participating in and complying with our Manufacturing Division Quality Management System (QMS) requirements.
Requirements
* Experience as a validation specialist in a pharmaceutical or highly regulated environment and 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.
Estimated Salary:
$120,000 - $150,000 per annum, depending on experience.