csv manufacturing engineer

Job Title: CSV Manufacturing Specialist

Location: North Caroline

Role Overview

We are seeking an experienced CSV Manufacturing Specialist to conduct a comprehensive review of previously executed work following an audit that identified numerous inconsistencies. The ideal candidate will play a crucial role in identifying gaps and quality issues within manufacturing-related systems and equipment, ensuring compliance and quality standards are met.

Key Responsibilities

• Conduct thorough reviews of manufacturing processes, batch records, and standard operating procedures (SOPs).
• Identify and document gaps and quality issues in existing processes and documentation.
• Remediate identified issues by updating documentation and revalidating systems as necessary.
• Collaborate with cross-functional teams to ensure compliance with regulatory standards and internal quality expectations.
• Prepare detailed reports and documentation of findings and remediation efforts.
• Engage in quality reviews and provide input on continuous improvement initiatives.
  
  

Qualifications

• Proven experience in CSV within a manufacturing environment, specifically related to regulatory compliance and quality assurance.
• Proficiency with Moda Engineering (Configuration) and Moda CSV is essential.
• Must have hands-on experience with Moda ES.
• Strong familiarity with quality reviews and relevant manufacturing processes.
• Excellent communication skills, with significant writing ability for documentation and reporting purposes.
• Ability to work independently and collaboratively in a fast-paced environment.