Job Title: Data Validation Specialist
We are seeking an experienced Data Validation Specialist to support our site-based validation activities across multiple platforms. As a key member of our team, you will be responsible for ensuring compliance with regulatory and internal requirements.
About the Role
The successful candidate will collaborate closely with Automation, Quality, and IT teams to validate critical GMP systems including MES, BMS, PCS, and various digital platforms. Your primary responsibilities will include:
1. Authoring, reviewing and executing Computer System Validation (CSV) protocols and reports in alignment with GAMP 5 and applicable regulations.
2. Supporting validation activities for site systems including Siemens MES, BMS, PCS, TrackWise, and CMX.
3. Leading validation planning and risk assessments for new systems and upgrades.
Requirements and Qualifications
To succeed in this role, you will need:
* Bachelor's degree in Engineering, Computer Science, or a related discipline.
* Minimum 3 years experience in a Computer System Validation or QA Validation role within the pharmaceutical or biopharmaceutical industry.
* Proven experience supporting validation of systems such as MES, PCS, BMS, TrackWise, CMX and GxP applications.
Preferred Skills
A working knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity principles is highly desirable. Experience with electronic document management systems such as Veeva Vault would also be beneficial.