Biotech jobs in United States

As a Validation Specialist, your primary focus will be supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment. This includes conducting IQ, OQ, and PQ studies to ensure optimal performance and output. Additionally, we are expanding our capabilities with the addition of a new Drug Product facility.

1. 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.
2. Act as the Subject Matter Expert for specific validation activities as designated by the Qualification and Calibration Manager.
3. Investigate and resolve non-conformances found during requalification, revalidation, and periodic review activities, with support from senior validation team members.
4. 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.
5. Identify and implement Continuous Improvement initiatives to promote lean processes.

1. Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
2. Strong understanding of qualification and validation lifecycles.
3. Knowledge of current regulatory requirements and industry standards related to validation activities.
4. Proven experience in executing qualification and validation tasks such as IQ, OQ, PQ.
5. Technical, compliance, and practical knowledge of specific validation activities, as guided by the Validation Manager.
6. Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
7. Proficient in creating and reviewing technical documentation.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at **********@proclinical.com.