
Biotechnology Validation Specialist
4 days ago
We are seeking a skilled Biotechnology Validation Specialist to join our team in a dynamic biotechnology landscape.
Key Responsibilities- Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
- Responsible for protocol writing and execution: draft, execute, review, and approve validation documentation ensuring it meets cGMP requirements, regulatory requirements, and quality standards.
- Draft and execute validation documentation, including:
- Validation Project & Master Plans
- Requirement Specifications (URS, DS, FS)
- IQ and OQ Test Scripts
- IQ/OQ/PQ Protocols
- Validation Summary Report
- 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 to ensure compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Closely collaborate with multiple departments on assigned project activities and deliverables.
- A degree in a relevant field of study or equivalent experience.
- Extensive knowledge of validation principles, regulations, and industry standards.
- Excellent communication and project management skills.
- Familiarity with laboratory and quality control procedures.
- A competitive compensation package that rewards your hard work and dedication.
- A comprehensive benefits structure that supports your well-being and career growth.
- Ongoing training and development opportunities to help you advance in your profession.
We are a leading provider of life sciences services, dedicated to helping clients succeed in the healthcare industry.
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