We are seeking an experienced **CSV Validation Specialist** with a strong background in IT validation, specifically within the pharmaceutical or healthcare industry. The ideal candidate will have prior experience working for **Johnson & Johnson** and a deep understanding of the **Software Development Life Cycle (SDLC)** framework, along with adherence to relevant procedures such as **SOP-1705**.
**Key Responsibilities:**
- **Validation Planning:** Develop and execute validation strategies for CSV projects, ensuring compliance with industry standards and company policies.
- **Documentation:** Create and maintain comprehensive validation documentation, including validation plans, protocols, and reports in accordance with SOP-1705 and other relevant SOPs.
- **Risk Assessment:** Perform risk assessments to identify potential validation issues and develop mitigation strategies.
- **Testing:** Lead and participate in the execution of CSV testing activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- **Collaboration:** Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to ensure all validation efforts meet project timelines and specifications.
- **Compliance:** Ensure adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.
- **Training:** Provide guidance and training to team members on CSV best practices and procedural compliance.
**Profile Requirements:**
**Experience:**
- Minimum of 3-5 years of experience in CSV validation, preferably in a regulated environment.
**SDLC Understanding:**
- Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.
**Documentation Skills:**
- Proven ability to create detailed, compliant documentation (SOPs, validation protocols, reports).
**Analytical Skills:**
- Strong analytical and problem-solving skills to identify issues and implement corrective actions.
**Preferred Qualifications:**
- Bachelor's degree in a related field (e.g., Computer Science, Information Technology, Engineering).
- Familiarity with industry standards and regulations relevant to CSV (e.g., GxP, 21 CFR Part 11).
- Experience with validation tools and methodologies.
**Why Join Us?**
At [Insert Company Name], we are committed to fostering a collaborative and innovative work environment. You will have the opportunity to work on impactful projects that contribute to the healthcare and pharmaceutical sectors. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.