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Csv Engineer Jobs

Csv Specialist Jobs
By IT Minds LLC At East Hanover, NJ, United States
Location- New Jersey (East Hanover) (On-Site)
cell and gene therapy equipment and instruments
Ability to develop following documents:
Quality Assurance Csv Engineer
By PSC Biotech At ,
Collaborate with cross functional teams to define requirements and specifications for computer systems validation.
3+ years of Computer System Validation (CSV) experience and at least 1 year of Quality Assurance experience.
Veeva experience is a plus.
Excellent communication skills, both verbal and written.
Excellent analytical and problem solving skills.
Excellent organization skills and ability to prioritize tasks and drive project completion.
Computer System Validation Engineer/ Csv
By Tech Aveev LLC At Nashville, TN, United States
variety of personalities, discipline skills and educational levels.
•Manage URS and FS, updating customer comments / review cycles.
•Must have a minimum of 4 years in the medical device industry/GMP experience.
. •Experience with Automation equipment for device assembly and testing.
•Knowledge of GAMP (Good Automated Manufacturing Practices) GMP and GDP.
• Demonstrate Excellent interpersonal skills with an ability to interact well with a
Csv Quality & Compliance Consultant
By Life Science People At United States
Flaunt strong project management aptitude, coupled with the prowess to judiciously prioritize tasks.
Execute comprehensive end user testing to validate flawless execution of PQ/UAT scripts, meticulously aligned with system-level user requirements.
Provide unwavering support for audit readiness initiatives and adeptly manage internal audit processes.
Demonstrate exemplary written and verbal communication skills.
Leverage your experience in executing end user testing and meticulously documenting software-related quality events.
Collaborate seamlessly with testing and validation teams to meticulously craft validation documentation that seamlessly adheres to regulatory requisites and standards.
Quality Assurance Csv Engineer
By PSC Biotech At , Philadelphia, 19019
In-depth knowledge of regulatory requirements and industry standards related to computer system validation.
Develop and execute computer system validation strategies and plans in accordance with regulatory requirements, industry standards, and company policies.
Support the validation plan, reviewing all necessary requirements for system data migration tasks and new system release efforts.
Review user requirements for current system software upgrades and new system user requirement specifications.
Ensure validation protocols meet user requirements, design configuration, and internal and industry regulatory requirements.
Review traceability matrix to ensure all requirements are linked to testing in order to determine functionality.
Csv Consultant Jobs
By Stellar Consulting Solutions, LLC At Kankakee, IL, United States
Experience with Alan Bradley systems such as Rockwell Automation Factory Talk, MES, PLC, SCADA. SIEMENS
Experience with Periodic CSV Review
Experience with manufacturing GMP Automation systems
No IT resource but someone who has worked in manufacturing site preferably from manufacturing background.
Periodic review of about 35 Automation systems and can be extended further to 200 odd systems.
Once onboarded will need to plan for periodic review of all the systems in scope and then start periodic review.
Csv/Di Consultant Jobs
By Compliance Group Inc At United States
Authoring and executing technical commissioning and qualification documentation
System requirements and description (URS)
Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.
Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
QA CSV/ CSA senior level resource that has experience
Csv Data Integrity Specialist
By LS Solutions At United States
CSV/DI Consultant that has experience with Data Integrity
Authoring and executing technical commissioning and qualification documentation
System requirements and description (URS)
Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.
Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
Csv Engineer Jobs
By Thrustex At Chicago, IL, United States
·System Validation Planning: Develop validation strategies and plans for our software platform, considering regulatory requirements and industry standards.
User Requirement Specification (URS): Collaborate with stakeholders to gather and document user requirements, ensuring they are accurately translated into functional specifications.
Functional Requirement Specification (FRS): Translate user requirements into detailed functional specifications that guide the design and development of our software platform.
Previous experience in computer system validation or a similar role within a regulated industry, such as pharmaceuticals, medical devices, or biotechnology.
A bachelor's or master's degree in a relevant field such as Computer Science, Engineering, or a related discipline.
Csv Associate Jobs
By Integrated Resources, Inc ( IRI ) At Carlsbad, CA, United States
Update Validation schedules matrix in Asset management software (BMRAM).
Coordinate protocol, SOP and final report approval in the electronic document management system and track the process.
Seeking recent grad, or someone with 1-2 years of experience.
Experience with: PLC Programming, PID Controller, SCADA, Ladder Logic
Prepare validation binders prior and post- qualification protocol execution.
Execute and/or review qualification protocols with guidance as needed.
Remote Csv And Quality Systems Contractor
By Real Staffing At Boston, MA, United States
Supports Veeva workflow for GLP, GCP, GMP and medical device issue management
6-month contract with possibility to extend
Supports the drafting and reviewing of validation documents: URS, FS, CS, DS,TM, VP, VSR, protocols/test scripts
Executes/reviews change controls, risk assessments, CAPAs and deviations as owner or reviewer
Develops and maintains all training materials, training records and curriculums in Veeva
Supports Veeva users with system issues on a daily basis
Csv Engineer Jobs
By Trinity Consultants - Advent Engineering Life Science Solutions At Boston, MA, United States
Knowledge and experience with GAMP5 Risk Based Approach to GxP Computerized Systems and risk assessment method is preferred
BS in a Computer Science or Engineering field or equivalent experience
5-15 years’ experience with Computer systems validation, including experience in authoring/reviewing/approving validation documentation (URS, Risk Assessment, IQ/OQ/PQ)
Deep 21CFR Part 11 experience is preferred
Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement
Strong background and understanding of FDA regulations
Sr. Quality Csv Specialist
By Compliance Group Inc At United States
Background in Medical Device industry is highly desired.Pharmaceutical experience only would be acceptable.
Technical Writing (author SOPs & Work Instructions)
Medical Device (pharmaceutical is fine)
This person will assume a hands-on role and report into the IT Business Partner.
This Candidate must have a background in the following:
Validation Engineer - Csv
By GSK At , Hamilton, 59840, Mt
Maintain up-to-date knowledge of validation requirements, practices, and procedures
Perform all job responsibilities in compliance with applicable EHS and GMP regulation, guidelines, policies, and standard operating procedures.
2+ years experience in Pharmaceutical industry or other regulated industry
HVAC, Smoke Studies, and EM Qualification
Technical writing organizational, communication and team skills.
We are looking for professionals with these required skills to achieve our goals:
Manager, Csv, Cell Therapy
By Bristol Myers Squibb At , Summit, 07901, Nj
Develops protocols, and associated reports while adhering to a change management process.
Experience executing equipment qualification documents
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Supports calibration, equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans,
It Qa Csv Consultant
By Azzur Group At ,

This position is responsible to Lead/ participate in NOE, EOE and CAPA; initiation, investigation, coordination and closure. Own and manage the IT deviation process which includes providing ...

Manager, Computer Systems Validation (Csv)
By Corcept Therapeutics At Menlo Park, CA, United States
Skills, Qualifications, Or Technical Proficiencies
Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies
Responsible to manage external CSV consultants in CSV projects
Thorough understanding of validation/qualification and concepts as it applies to pharmaceuticals quality systems
Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions
Experience with CTMS and Regulatory systems
Senior Qa Specialist, Csv
By ExcelGens, Inc. At Harmans, MD, United States
Bachelor’s degree in a Science or Engineering field with 6 years of experience or Master’s degree with 3 years of experience.
Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
Able to work in a team setting and independently under minimum supervision.
Ensure site systems are compliant with the corporate Data Integrity program.
Provide QA support to enforce CSV guidelines, policies and procedures for control systems, automation, analytical equipment, and IT applications
Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives
Csv Analyst Jobs
By Digital Infuzion At Washington DC-Baltimore Area, United States
Report and track any significant deviations from quality standards and recommend corrective actions to appropriate management stakeholders.
Management of the MasterControl eQMS.
Support the organization and professional services team with process improvements in order to confirm changes are compliant with specific regulatory requirements.
Bachelor’s degree in Computer Science, Information Systems, Information Technology, or equivalent experience.
At least 2 years related experience
Experience administering an eQMS system such as MasterControl
Csv Analyst Jobs
By Steady Rabbit At Boston, MA, United States
Implementation of qualification / validation activities within projects of new and existing computer systems according to our client requirements
At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems
Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
Advisory and support of application owners to build and maintain GxP conform systems.
Support and consulting during projects handling GxP critical computer systems
Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity)

Are you a CSV Engineer looking for an exciting new challenge? We are looking for a talented and motivated individual to join our team and help us develop and maintain our CSV systems. You will be responsible for designing, developing, and maintaining CSV systems that meet our company's needs. You will also be responsible for troubleshooting and resolving any issues that arise. If you have a passion for engineering and are looking for a rewarding career, then this is the job for you!

Overview:

A CSV Engineer is responsible for developing, testing, and maintaining software applications that use comma-separated values (CSV) files. They must be able to interpret and analyze data, create efficient algorithms, and develop software solutions. They must also be able to troubleshoot and debug software applications.

Detailed Job Description:

A CSV Engineer is responsible for developing, testing, and maintaining software applications that use comma-separated values (CSV) files. They must be able to interpret and analyze data, create efficient algorithms, and develop software solutions. They must also be able to troubleshoot and debug software applications. They must have a strong understanding of data structures, algorithms, and software engineering principles. They must also be able to work with a variety of programming languages, including Java, Python, and C++.

What is Csv Engineer Job Skills Required?

• Strong understanding of data structures, algorithms, and software engineering principles
• Ability to interpret and analyze data
• Ability to create efficient algorithms
• Ability to develop software solutions
• Ability to troubleshoot and debug software applications
• Proficiency in programming languages such as Java, Python, and C++
• Ability to work independently and in a team environment
• Excellent problem-solving and communication skills

What is Csv Engineer Job Qualifications?

• Bachelor’s degree in Computer Science, Software Engineering, or a related field
• At least two years of experience in software engineering
• Knowledge of database systems such as MySQL and Oracle
• Knowledge of web development technologies such as HTML, CSS, and JavaScript
• Knowledge of version control systems such as Git and SVN

What is Csv Engineer Job Knowledge?

• Knowledge of data structures, algorithms, and software engineering principles
• Knowledge of programming languages such as Java, Python, and C++
• Knowledge of database systems such as MySQL and Oracle
• Knowledge of web development technologies such as HTML, CSS, and JavaScript
• Knowledge of version control systems such as Git and SVN

What is Csv Engineer Job Experience?

• At least two years of experience in software engineering
• Experience with developing software applications that use CSV files
• Experience with troubleshooting and debugging software applications

What is Csv Engineer Job Responsibilities?

• Develop, test, and maintain software applications that use CSV files
• Interpret and analyze data
• Create efficient algorithms
• Develop software solutions
• Troubleshoot and debug software applications
• Work with a variety of programming languages