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Location

King of Prussia, PA | United States

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Job description

Position: Computer System Validation (CSV) Specialist

Duration : 6-12 Months

Location: King of Prussia, Philadelphia (Onsite)

Job Summary :

A dedicated and detail-oriented CSV Specialist is required for an on-site position to ensure the integrity and compliance of computerized systems within pharmaceutical manufacturing.

The specialist will be responsible for the validation of Enterprise IT systems, standalone laboratory and manufacturing equipment, maintaining audit readiness and experience with audit trail review programs.

Key Responsibilities :

• Lead validation efforts for computerized systems in accordance with FDA requirements and industry best practices.
• Perform hands-on validation activities for Enterprise IT systems, Lab and MFG equipment, including writing and executing validation protocols.
• Develop and maintain a robust audit trail review program to ensure data integrity and compliance.
• Prepare and manage documentation for all validation activities and ensure readiness for internal and external audits.
• Collaborate with cross-functional teams to ensure system compliance with all regulatory requirements.

Qualifications :

• Bachelor's degree in a related field preferred but not mandatory; an advanced degree is a plus.
• Extensive experience in computer system validation within the pharmaceutical manufacturing industry.
• In-depth knowledge of GxP, 21 CFR Part 11, and other relevant regulatory guidelines.
• Proven track record of successful validation of laboratory and manufacturing equipment.
• Strong understanding of audit processes and experience in audit trail reviews.
• Excellent problem-solving skills and attention to detail.

Best Regards,

Vishal

630-625-8599-Fax

[email protected]

Truth Lies in Heart

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Salary