Website Karwell Technologies
Karwell Technologies
Company : Karwell Technologies
Job Description:
- We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.
- This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).
Roles & Responsibilities:
- Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment
- Ensure compliance with GMP and 21 CFR Part 11 standards
- Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures
- Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance monitoring
- Perform instrument calibration for equipment such as dual display light meters, open air shakers, and various scales
- Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclaves
- Execute validation projects, ensuring timelines, budgets, and KPIs are met
- Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepancies
- Apply a risk-based approach to validation to ensure compliance and operational efficiency
- Coordinate resources and activities for complex validation and CSV initiatives
- Requirements:
- Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment.
- Strong knowledge of GMP and 21 CFR Part 11 compliance.
- Proven experience with Computerized System Validation (CSV).
- Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation.
- Strong problem-solving, communication, and cross-functional collaboration skills.