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Job Description
CSV Engineer Job Description
Develop and implement computer and automation systems validation processes to ensure compliance with regulatory requirements.
Responsibilities:
- Develop and implement validation processes for computer and automation systems
- Coordinate and execute training for personnel on validation procedures and methodology
- Keep systems and processes up to date and compliant
- Provide guidance on validation activities
- Support activities including SOP creation, documentation review, and approval
- Compile and analyze validation data and make recommendations for changes and improvements
- Investigate and troubleshoot problems and determine solutions
- Maintain all documentation pertaining to computer systems validation
- Participate on cross-functional project teams
Requirements:
- Bachelor's degree in a technical, scientific, or related field
- Minimum 6 years of related industry experience
- Minimum 3 years of experience in CSV system development life cycle
- Validation experience with ERP, MES, LIMS, and Quality Systems
- Thorough knowledge of cGMP regulations related to CSV
- Strong knowledge of system development life cycle
- Strong leadership skills and ability to work in cross-functional team environments
About Johnson & Johnson Innovative Medicine:
Johnson & Johnson Innovative Medicine is a leading pharmaceutical company that develops and manufactures innovative medicines to address complex diseases.
Benefits:
- Competitive hourly rate
- 12-month contract with strong chance of extension