Get new jobs for this search by email
Computer System Validation Engineer
Katalyst Healthcares and Life Sciences - Scottsdale 1 days ago
Responsibilities: Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regula...
More...
Computer System Validation Engineer
Katalyst Healthcares and Life Sciences - Jersey City 1 days ago
Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, v...
More...
Computer System Validation Specialist
Quality Chemical Laboratories - Wilmington, North Carolina, United States, 28405 1 days ago
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for...
More...
Computer System Validation Engineer
Katalyst Healthcares and Life Sciences - Libertyville 1 days ago
Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems suppor...
More...
Computer System Validation Engineer
Technoviz - Madison 1 days ago
Benefits: nCompetitive salary nOpportunity for advancement nTraining & development nJob Summary nWe are seeking ...
More...
Computer System Validation Specialist
Katalyst HealthCares & Life Sciences - South Plainfield, New Jersey, us, 07080 1 days ago
Job TitleResponsibilities: Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) del...
More...
Computer System Validation Engineer
Abeona Therapeutics - Cleveland 1 days ago
Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Compu...
More...
Computer System Validation Engineer
Diverse Lynx - Santa Clara 1 days ago
Role: Computer System Validation Engineer Location: Santa Clara, CA (Onsite) Job type: Contract
More...
Sr. Computer system Validation Engineer
Katalyst Healthcares and Life Sciences - St Joseph 1 days ago
Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, ...
More...
Go to next pageKatalyst Healthcares and Life Sciences
Katalyst Healthcares and Life Sciences - Scottsdale
Work at Katalyst Healthcares and Life Sciences
Responsibilities: - Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations.
- Develop, review, and approve validation documents, including validation plans, test scripts, and final reports.
- Coordinate and conduct validation activities in accordance with project timelines and business objectives.
- Implement and manage document control processes and systems.
- Evaluate and recommend improvements to existing systems and processes to enhance efficiency and compliance.
- Provide technical support and training to other team members on computer system validation and related topics.
- Participate in internal and external audits, ensuring all computer systems are compliant.
- Oversee ERP implementation, ensuring seamless integration with existing systems.
- Stay updated with the latest industry trends, regulations, and validation standards.
Requirements: - Bachelor's degree in computer science, Engineering, or a related field.
- A minimum of 5 years of experience in Computer System Validation (CSV) in the engineering industry.
- Proficient knowledge of Document Control, 21 CFR Part 11, FDA regulations, cGMP regulations, and CSV.
- Proven experience in ERP implementation.
- Strong understanding of computer systems, including hardware, software, networking, and security.
- Excellent problem-solving skills and the ability to handle multiple projects simultaneously.
- Strong written and verbal communication skills.
- Ability to work in a team and independently as needed.
- High attention to detail and accuracy.
- Proactive, self-motivated, and able to work under minimal supervision.
- Certification in Computer System Validation or a related field would be an added advantage.
See details and apply
Computer System Validation Engineer
