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Manufacturing CSV Specialist
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Job Description
- Req#: 25-00625
Employer Industry: Engineering and IT Business Solutions
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work remotely with flexible scheduling options
- Engage in diverse projects across various enterprise systems
- Collaborate with cross-functional teams in a supportive environment
- Be part of a leading provider serving over 1,000 clients in commercial and government sectors
What to Expect (Job Responsibilities):
- Lead and manage computer system validation (CSV) projects, authoring and executing validation documentation for enterprise systems
- Develop validation protocols ensuring compliance with regulatory standards such as 21 CFR Part 11 and GxP
- Conduct risk assessments and prepare validation summary reports aligned with GMP requirements
- Investigate and support resolution of deviations, CAPAs, and other quality system activities
- Validate software for manufacturing instruments while managing multiple concurrent validation projects
What is Required (Qualifications):
- 7+ years of experience in FDA-regulated industries with strong knowledge of GMP, 21 CFR Part 11, and Annex 11
- 5+ years of experience in document authoring, SOP revisions, and protocol re-execution
- Demonstrated ability to manage multiple concurrent validation or system implementation projects
- Experience validating software for manufacturing instruments and enterprise systems
- Excellent written and verbal communication skills; strong collaborator with cross-functional teams
How to Stand Out (Preferred Qualifications):
- Proficient in both traditional (V-Model) and modern (CSA) validation approaches
- Familiarity with Agile and Waterfall methodologies in system and software development environments
- Self-motivated, adaptable, and customer-focused with a proactive approach to leadership and problem-solving
#Engineering #ITBusinessSolutions #RemoteWork #CareerGrowth #ValidationSpecialist
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