Company Description
PACIV, Inc., founded in 1997 in Puerto Rico, specializes in process automation, controls, instruments, and validations. With offices in Indiana, USA, and Cork, Ireland, PACIV provides life sciences automation and regulatory compliance solutions. The company aims to meet the needs of multinational clients by offering localized market formats and consistent implementation. PACIV holds Master Service Agreements and Preferred Vendor status with leading Life Science companies, demonstrating its standing within the industry. The company is dedicated to attracting and developing the best talent to deliver significant value through its automation solutions and services.
Role Description
This is a full-time, on-site role for a Junior CSV Validation Engineer located in Dublin. The Junior CSV Validation Engineer will be responsible for conducting Computer System Validations (CSV), ensuring compliance with regulatory standards, and maintaining documentation. Day-to-day tasks include creating and executing validation protocols, managing deviations, and performing risk assessments. Additionally, the role involves collaborating with cross-functional teams to support validation activities and ensuring project timelines are met.
Qualifications
* Experience in Computer System Validation
* Knowledge of regulatory standards in the Life Sciences industry (e.g., GxP, FDA 21 CFR Part 11)
* Proficiency in technical writing and documentation, including validation protocols and reports
* Strong analytical and problem-solving skills
* Ability to collaborate effectively with cross-functional teams
* Excellent communication and organizational skills
* Bachelor's degree in Engineering, Computer Science, or related field
* Experience in the Life Sciences industry is a plus