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Csv Manager Jobs in Puerto Rico (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA ...

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

Manage deviations, investigations, change controls, and validation documentation. * Develop CSV training plans and training matrices. * Monitor CSV milestones, schedules, and project deliverables.

PACIV

IT / CSV Specialist

San Juan, PR · On-site

Manage GxP user accounts, roles, access reviews, and Active Directory permissions. * Coordinate ... Experience authoring CSV documentation, including IQ/OQ/PQ protocols. * Familiarity with GAMP 5 and ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Develop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch ...

Three Point Solutions

PR · On-site

$80 - $110/hr

Oversee CSV, IQ/OQ/PQ validation * Ensure FDA, ISO 13485, GxP, 21 CFR Part 11 compliance * Support ... Manage stakeholders * Escalation point for risks and constraints Governance & Reporting * Executive ...

JC Automation Corp

PR · On-site

$25 - $35/hr

Validation Support: Assist in the execution of validation protocols, testing activities, CSV ... Knowledge of Kneat Software or equivalent validation management tools. SKILLS Technical Skills

FITS LLC

Project Engineer - Automation

Manati, PR · On-site

... management experience, including 4+ years in process automation and 2+ years in CSV. * Strong knowledge of cGMP, FDA/EMA regulations, and 21 CFR Part 1 * Bilingual: Spanish and English (verbal ...

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Csv Manager information

What is a CSV manager?

A CSV Manager is a software tool or professional responsible for handling, organizing, and processing CSV (Comma-Separated Values) files. These files are commonly used for storing and exchanging data in a simple text format, making them popular for data imports and exports in various applications. A CSV Manager ensures that the data within these files is correctly formatted, validated, and sometimes transformed for compatibility with databases or other systems. They may also automate workflows involving large amounts of CSV data to improve efficiency and accuracy.

What are the key skills and qualifications needed to thrive as a CSV manager?

To thrive as a CSV (Computer System Validation) Manager, you need a strong background in GxP regulations, validation methodologies, and a degree in life sciences, engineering, or a related field. Familiarity with validation lifecycle documentation, risk assessment tools, and regulatory standards like FDA 21 CFR Part 11 is typically required. Outstanding project management, attention to detail, and strong communication skills make a CSV Manager stand out in ensuring compliance and leading cross-functional teams. These competencies are crucial for ensuring validated systems meet regulatory requirements and support business operations in highly regulated industries.

What are some common challenges faced by a CSV manager in maintaining regulatory compliance across multiple projects?

A CSV (Computer System Validation) Manager often manages several projects simultaneously, each with unique regulatory requirements. One major challenge is ensuring that all validation documentation remains current and audit-ready, despite frequent software updates or process changes. Additionally, coordinating with cross-functional teams such as IT, Quality Assurance, and Operations can be demanding, as priorities and timelines may differ. Staying updated with evolving industry regulations and effectively training team members are also essential to maintaining consistent compliance.

What is the difference between Csv Manager vs Data Analyst?

AspectCsv ManagerData Analyst
Required CredentialsExperience with CSV data management, basic database skillsDegree in statistics, data science, or related field; proficiency in data analysis tools
Work EnvironmentData management teams, IT departmentsBusiness analysis teams, research departments
Employer & Industry UsageUsed in industries handling large CSV datasets, such as logistics and financeUsed across industries for interpreting data, reporting, and decision-making

The Csv Manager primarily focuses on managing and organizing CSV data files, ensuring data integrity and accessibility. In contrast, a Data Analyst interprets data, creates reports, and provides insights. While both roles work with data, Csv Managers specialize in data handling, whereas Data Analysts focus on analysis and interpretation.

What are popular job titles related to Csv Manager jobs in Puerto Rico?

For Csv Manager jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Csv Manager jobs in Puerto Rico look for?

The top searched job categories for Csv Manager jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Csv Manager jobs?

Cities in Puerto Rico with the most Csv Manager job openings:

Csv Manager jobs near you

CSV Specialist

Gurabo, PR • On-site

Mirus Consulting Group
See more jobs at Mirus Consulting Groupexternal

Full-time

Re-posted 10 days ago

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary:
The CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across manufacturing and quality systems, with a strong focus on parenteral processes and regulated environments.
Key Responsibilities:
  • Develop, review, and execute CSV deliverables including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
  • Ensure that computerized systems meet data integrity and regulatory compliance requirements.
  • Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and Manufacturing teams.
  • Participate in impact assessments, change control activities, and periodic system reviews.
  • Provide technical and compliance support during internal and external audits.
  • Maintain validation documentation in alignment with company quality systems and GAMP 5 guidance.
  • Support troubleshooting, deviation resolution, and CAPA implementation related to validated systems.
  • Promote continuous improvement and standardization of CSV practices across site operations.

Qualifications & Requirements:
  • Bachelor’s Degree in engineering
  • Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry.
  • Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11, and GAMP 5.
  • Experience with parenteral operations or aseptic manufacturing environments preferred.
  • Excellent documentation, communication, and teamwork skills.
  • Fully bilingual (Spanish/English) preferred.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.