Senior Validation Specialist
4 weeks ago
Job Title: Senior Validation Specialist
Job Summary:
We are seeking a highly skilled Senior Validation Specialist to join our team at Proclinical Staffing. As a Senior Validation Specialist, you will be responsible for supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment.
Key Responsibilities:
- Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry standards.
- Act as the Subject Matter Expert for specific validation activities as designated by the Qualification and Calibration Manager.
- Investigate and resolve non-conformances found during requalification, revalidation, and periodic review activities, with support from senior validation team members.
- Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented.
- Identify and implement Continuous Improvement initiatives to promote lean processes.
Key Requirements:
- Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
- Strong understanding of qualification and validation lifecycles.
- Knowledge of current regulatory requirements and industry standards related to validation activities.
- Proven experience in executing qualification and validation tasks such as IQ, OQ, PQ.
- Technical, compliance, and practical knowledge of specific validation activities, as guided by the Validation Manager.
- Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
- Proficient in creating and reviewing technical documentation.
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