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:
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.
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 ...

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)
Csv/Mechanical Engineer Jobs
By PSC Biotech At , Houston, 77006, Tx
Keep up to date with advances in the field and the regulatory requirements.
Additional duties and responsibilities may be assigned from time to time.
Write, review, and approve of validation SOPs and documentation.
Involvement in review and updating of validation documentation.
Review and analyze validation data – compiling reports when required.
Assist and recommend process upgrades and improvements in efficiency.

Are you a data-driven problem solver? Do you have a passion for uncovering insights from large datasets? We are looking for a CSV Analyst to join our team and help us make data-driven decisions. You will be responsible for analyzing large datasets, creating reports, and developing data-driven solutions. If you are an analytical thinker with a knack for finding patterns in data, this is the perfect job for you!

Overview A CSV Analyst is a data analyst who specializes in working with Comma Separated Value (CSV) files. They are responsible for analyzing, validating, and manipulating data stored in CSV files. They must be able to interpret the data and draw meaningful conclusions from it. They must also be able to create reports and visualizations to present their findings. Detailed Job Description A CSV Analyst is responsible for analyzing, validating, and manipulating data stored in CSV files. They must be able to interpret the data and draw meaningful conclusions from it. They must also be able to create reports and visualizations to present their findings. They must be able to identify and troubleshoot any errors or inconsistencies in the data. They must also be able to develop and implement data-driven solutions to improve the accuracy and reliability of the data. Job Skills Required
• Knowledge of data analysis techniques and tools
• Knowledge of database management systems
• Proficiency in SQL and other programming languages
• Ability to interpret data and draw meaningful conclusions
• Ability to create reports and visualizations
• Ability to identify and troubleshoot errors and inconsistencies in data
• Ability to develop and implement data-driven solutions
• Excellent communication and problem-solving skills
Job Qualifications
• Bachelor’s degree in Computer Science, Information Technology, or a related field
• Experience working with CSV files
• Experience with data analysis, database management, and programming
• Knowledge of SQL and other programming languages
• Knowledge of data analysis techniques and tools
Job Knowledge
• Knowledge of data analysis techniques and tools
• Knowledge of database management systems
• Proficiency in SQL and other programming languages
• Knowledge of data visualization techniques
• Knowledge of data security and privacy regulations
Job Experience
• Experience working with CSV files
• Experience with data analysis, database management, and programming
• Experience with data visualization techniques
• Experience with data security and privacy regulations
Job Responsibilities
• Analyze, validate, and manipulate data stored in CSV files
• Interpret data and draw meaningful conclusions
• Create reports and visualizations to present findings
• Identify and troubleshoot errors and inconsistencies in data
• Develop and implement data-driven solutions
• Monitor data security and privacy regulations
• Maintain accurate and up-to-date records of data analysis activities