Validation Specialist
6 days ago
The role of a Validation Specialist is to oversee the entire lifecycle of validation activities, ensuring compliance with relevant regulations and industry standards.
This position requires a deep understanding of validation principles, protocols, and procedures, as well as excellent communication and project management skills.
The successful candidate will have experience in pharmaceutical or biopharmaceutical manufacturing facilities, with knowledge of GxP environments and regulatory requirements.
Key Responsibilities- Develop and execute validation plans, protocols, and reports.
- Coordinate with cross-functional teams to ensure seamless integration of validation activities.
- Perform risk-based commissioning, qualification, and validation of equipment, utilities, and facilities.
- Assist in developing user requirements specification documents and design review documents.
- Generate protocols and execute field work related to installation and operational qualification.
- Prepare and execute performance qualification, computerized system validation, cleaning validation, thermal validation, and transport qualification activities.
- Degree and/or diploma in engineering, science, or related studies.
- Minimum 1-3 years' experience in pharmaceutical/biopharmaceutical manufacturing facility.
- Familiarity with working in a GxP environment and keeping up-to-date with current GxP regulations.
- Good knowledge of GxP, GDP, CQV approaches, and regulatory requirements.
- Competent in technical writing and presentations.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
A challenging and rewarding role in a dynamic organization, with opportunities for professional growth and development.
Collaborative and supportive work environment, with a focus on teamwork and open communication.
Competitive salary and benefits package, including opportunities for travel and professional training.
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