Validation and Qualification Expert
4 days ago
This position involves providing high-quality oversight for validation, qualification, and replacement of manufacturing process equipment. You will assess and approve acceptance tests, reports, and documentation, ensuring compliance with relevant policies and standards.
You will collaborate with cross-functional teams to plan, coordinate, and execute validation procedures efficiently. Your expertise will include reviewing and authorizing engineering changes, deviations, and exceptions during validation activities.
This role requires strong analytical and problem-solving skills, with the ability to maintain accurate records and reports. You will also need excellent communication and interpersonal skills to work effectively with stakeholders.
About You- Proven experience in equipment validation within a GMP-regulated environment.
- Degree in Engineering, Life Sciences, or a related field (preferred).
- Expertise in cGMP standards and regulatory compliance for equipment validation.
- Knowledge of validation protocols, deviations, and change requests.
- Leadership and coordination skills for validation activities.
- Problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
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