CSV Specialist
10 hours ago
Mentor Technical Group is seeking a highly skilled CSV Specialist to join our team. As a CSV Specialist, you will be responsible for performing activities related to validations, customer complaints, and documentation lifecycle closeout.
Responsibilities:- Perform activities related to validations, customer complaints, and documentation lifecycle closeout.
- Investigate client complaints, issues, and applicable reports, and recommend solutions.
- Write, revise, and execute Commissioning/Qualification/Validation documents, following established standards and templates.
- Coordinate execution activities as required by commissioning, qualification, validation protocols.
- Provide support to vendors' installation and commissioning, qualification, validation activities.
- Bachelor's degree in Engineering, Pharmacy, or Science-related fields.
- Formal education and training on Equipment/System validation concepts and life cycle.
- Hands-on experience in the development and/or review of decommissioning life cycle documentation and reports.
- Hands-on experience in CQV protocols execution.
- Excellent communication skills (English and Spanish).
The CSV Specialist will work in a fast-paced environment, collaborating with cross-functional teams to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.
The ideal candidate will have a strong understanding of equipment/system validation concepts, life cycle, and documentation requirements. They will be able to work independently and as part of a team, with excellent communication and problem-solving skills.
Mentor Technical Group is an equal opportunity employer and welcomes applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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