Creation and review of validation deliverables including but not limited to Requirement ... Good knowledge and experience of CSV activities but not limited to. * GxP and 21 CFR Part 11 ...
Creation and review of validation deliverables including but not limited to Requirement ... Good knowledge and experience of CSV activities but not limited to. * GxP and 21 CFR Part 11 ...
Computer validation Engineer
Fort Washington, PA · On-site
$107K - $127K/yr
This project is to perform engineering modifications and CSV validation to an automated control system utilizing Wonderware InTouch, InBatch and ArchestrA and Allen Bradley Control Logix PLCs.
Computer validation Engineer
Fort Washington, PA · On-site
$107K - $127K/yr
This project is to perform engineering modifications and CSV validation to an automated control system utilizing Wonderware InTouch, InBatch and ArchestrA and Allen Bradley Control Logix PLCs.
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
Mandatory Skills 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test ...
Mandatory Skills 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test ...
Validation Engineer
Boston, MA · On-site
Validation Engineer Location: Boston, MA Overview This engagement supports a large-scale Quality ... CSV / Part 11 exposure * Experience with high-volume documentation remediation Thanks & Regards ...
Quick apply
Validation Engineer
Boston, MA · On-site
Validation Engineer Location: Boston, MA Overview This engagement supports a large-scale Quality ... CSV / Part 11 exposure * Experience with high-volume documentation remediation Thanks & Regards ...
Senior Validation Engineer (CSV), Biotechnology - (JP15063) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: Commercial Drug Product Duration: 9+ months (with likely ...
Senior Validation Engineer (CSV), Biotechnology - (JP15063) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: Commercial Drug Product Duration: 9+ months (with likely ...
CSV Validation QC Engineer
Jersey City, NJ · On-site
Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...
CSV Validation QC Engineer
Jersey City, NJ · On-site
Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...
CSV Validation Supervisor
Hickory, NC · On-site
... as engineering and quality assurance groups to ensure successful project execution Lead cross-functional project teams in the development of validation deliverables Review and approve validation ...
CSV Validation Supervisor
Hickory, NC · On-site
... as engineering and quality assurance groups to ensure successful project execution Lead cross-functional project teams in the development of validation deliverables Review and approve validation ...
Quality Validation Engineer
Devens, MA · On-site
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · On-site
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Quality Validation Engineer
Devens, MA · Hybrid
Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS ... by Operations/Engineering. * Serve as site Validation/CSV subject matter expert for internal ...
Field Validation Engineer
Saint Louis, MO · Remote
The Field Validation Engineer at Rees Scientific is responsible for executing validation and ... Support computer system validation (CSV) activities in alignment with GAMP and data integrity ...
Quick apply
Field Validation Engineer
Saint Louis, MO · Remote
The Field Validation Engineer at Rees Scientific is responsible for executing validation and ... Support computer system validation (CSV) activities in alignment with GAMP and data integrity ...
Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT ... Demonstrated experience in computer systems validation (CSV) for building management or automation ...
Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT ... Demonstrated experience in computer systems validation (CSV) for building management or automation ...
I have an opportunity for "Validation Engineer -Hamilton, OH - Onsite" and I am looking for a ... CSV background as well and help write CSV deliverables Someone who can be onsite Someone who can ...
I have an opportunity for "Validation Engineer -Hamilton, OH - Onsite" and I am looking for a ... CSV background as well and help write CSV deliverables Someone who can be onsite Someone who can ...
Arthur Lawrence is looking for a Validation Engineer/Technician with CSV / CQV Focus one of our clients in Worcester, MA. Please find the below and send us your updated resume if interested: Must ...
Arthur Lawrence is looking for a Validation Engineer/Technician with CSV / CQV Focus one of our clients in Worcester, MA. Please find the below and send us your updated resume if interested: Must ...
Be Seen First
Junior Validation Engineer / CQV
Albany, NY · On-site
$37 - $42/hr
Support Computerized System Validation (CSV) activities * Assist in validation of autoclaves, CIP ... Collaborate with Quality, Manufacturing, and Engineering teams to resolve validation issues
Quick apply
Be Seen First
Junior Validation Engineer / CQV
Albany, NY · On-site
$37 - $42/hr
Support Computerized System Validation (CSV) activities * Assist in validation of autoclaves, CIP ... Collaborate with Quality, Manufacturing, and Engineering teams to resolve validation issues
Field Validation Engineer
Cleveland, OH · On-site
The Field Validation Engineer at Rees Scientific is responsible for executing validation and ... Support computer system validation (CSV) activities in alignment with GAMP and data integrity ...
Quick apply
Field Validation Engineer
Cleveland, OH · On-site
The Field Validation Engineer at Rees Scientific is responsible for executing validation and ... Support computer system validation (CSV) activities in alignment with GAMP and data integrity ...
Are you a skilled Validation Engineer with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant ...
Are you a skilled Validation Engineer with a passion for ensuring quality in the pharmaceutical industry? Verista is actively seeking talented professionals to join our team in the vibrant ...
Equipment Validation Engineer
Raleigh, NC · On-site
This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV ...
Equipment Validation Engineer
Raleigh, NC · On-site
This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV ...
Csv Validation Engineer information
See salary details
$22.60 - $27.64
2% of jobs
$27.64 - $32.69
6% of jobs
$32.69 - $37.74
13% of jobs
$39.32 is the 25th percentile. Wages below this are outliers.
$37.74 - $42.79
13% of jobs
$42.79 - $47.84
11% of jobs
The median wage is $50.36 / hr.
$47.84 - $52.88
12% of jobs
$52.88 - $57.93
9% of jobs
$61.82 is the 75th percentile. Wages above this are outliers.
$57.93 - $62.98
13% of jobs
$62.98 - $68.03
13% of jobs
$68.03 - $73.08
6% of jobs
$73.08 - $78.13
3% of jobs
$22
$51
$78
How much do csv validation engineer jobs pay per hour?
What are the key skills and qualifications needed to thrive as a CSV Validation Engineer, and why are they important?
What are Csv Validation Engineers?
What are some common challenges faced by a CSV Validation Engineer when working with cross-functional teams?
What is the difference between Csv Validation Engineer vs Data Quality Analyst?
| Aspect | Csv Validation Engineer | Data Quality Analyst |
|---|---|---|
| Required Credentials | Bachelor's in Computer Science, Data Management, or related field; familiarity with data validation tools | Bachelor's in Data Science, Statistics, or related; certifications like CDMP are common |
| Work Environment | Data teams, software development, quality assurance | Data analysis, reporting, data governance teams |
| Industry Usage | Tech, finance, healthcare, where data validation is critical | Business intelligence, analytics, data management sectors |
The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.
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Contractor
Posted 17 days ago
Job description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Responsibilities:
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
- Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
- Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
- Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
- Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
- Traceability Matrix.
- Periodic Reviews.
- System Retirement/Decommissioning.
- Execution of Dry/Test protocol run.
- Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
- Perform System Retirement/Decommissioning of systems not in business.
- Work closely with software development and IT teams to establish best practices for quality and compliance.
- Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
- Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
Requirements:
- A Minimum bachelor's degree in engineering, Science or related technical field.
- Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
- Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Experience with non-product software validation, including tools for development, testing, and maintenance.
- Good knowledge and experience of CSV activities but not limited to.
- GxP and 21 CFR Part 11 applicability/criticality assessment.
- Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
- Execution of Dry/Test protocols.
- Conduct Periodic Reviews of systems.
- Perform System Retirement of systems that are not in business.
- Understanding of Medical Device Quality and Compliance.
- Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
- Working experience in Product Lifecycle Management (PLM) tool.
- Sound knowledge of computer system development lifecycles.
- Knowledge of JIRA, JAMA software and test automation is a plus.
All your information will be kept confidential according to EEO guidelines.
About Katalyst Healthcares & Life Sciences
Sourced by ZipRecruiter
Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US