Gxp Facility Validator
1 week ago
We are seeking a highly skilled Commissioning Qualification Validation Engineer to join our team.
- The ideal candidate will possess excellent problem-solving skills and have a strong background in commissioning, qualification, and validation of GxP facilities, equipment, and utilities.
- Solid understanding of cGMP requirements, regulatory guidelines, and quality standards is essential for this role.
Key Responsibilities:
- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Draft, execute, review, and approve validation documentation ensuring it meets cGMP requirements, regulatory requirements, and quality standards.
- Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommend process improvements where needed ensuring compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Collaborate with multiple departments on assigned project activities and deliverables.
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