Job Overview
We are seeking a dedicated and knowledgeable CSV (Computer System Validation) Specialist to support qualification activities used in manufacturing & packaging environment. The successful candidate will ensure that the system meets all applicable regulatory requirements and internal standards through comprehensive validation and documentation.
Key Responsibilities:
- Plan, develop and execute qualification and validation protocols (IQ, OQ, PQ).
- Ensure compliance with GxP, FDA, and other relevant regulatory guidelines.
- Collaborate with cross-functional teams (Engineering, QA, IT, Production) to gather system requirements and functional specifications.
- Review and validate Manufacturing & Packaging Equipment
- Draft and maintain CSV documentation, including Risk Assessments, Traceability Matrices, Validation Plans, and Reports.
- Support periodic review, change control, and revalidation activities for the system.
- Identify and troubleshoot validation issues, providing timely resolutions.
- Assist in audits and inspections by providing documentation and expert knowledge of the validated system.
Requirements:
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
- Minimum (4) years of experience in CSV, preferably in a pharmaceutical, biotech, or regulated manufacturing environment.
- Hands-on experience with Manufacruing & Packaging equipment.
- Must possess hands-on experience with automation systems.
- Strong understanding of validation principles and GxP regulatory requirements.
- Proficient in writing and executing IQ/OQ/PQ protocols.
- Excellent documentation, communication, and problem-solving skills.
Available to Work:
- Job Type: Contract
- Work Location: In person
Work Location: In person
