Validation and Compliance Professional

4 days ago


Summit, New Jersey, United States Axelon Full time
Axelon is seeking an experienced Validation and Compliance Professional. The estimated salary for this role is $125,000 per year.

**Overview:**
Axelon is a leading provider of IT solutions, and we are looking for a skilled Validation and Compliance Professional to join our team. As a Validation and Compliance Professional, you will play a critical role in ensuring that our clients' systems meet the highest standards of quality and compliance.

**Responsibilities and Expectations:**
The Validation and Compliance Professional will be responsible for executing validation activities and preparing validation deliverables for the S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role will require working closely with site business owners, CI owners, quality, and the global EMES team to ensure that all computerized systems/recipes validation deliverables meet regulatory requirements and industry standards.

The specialist will also be responsible for ensuring that the validation of electronic batch records (EBR) and review by exception (RBE) are performed correctly and efficiently. Additionally, the specialist will validate recipe authoring/validation and participate in a 12x7 on-call support rotation.

**Requirements and Qualifications:**
- Bachelor's degree in a life sciences, engineering, or technology discipline required
- Minimum of 2+ years of relevant work experience required, preferably in a pharmaceutical manufacturing environment

We offer a competitive salary and benefits package, as well as opportunities for career growth and development.

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