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Csv Validation Consultant Jobs in Puerto Rico (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

$60 - $80/hr

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$150 - $200/hr

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys ... quality validation documentation Why Join Technical & Engineering Consulting? At Technical ...

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Csv Validation Consultant information

What does a CSV Validation Consultant do?

A CSV Validation Consultant specializes in ensuring that computer systems used in regulated industries, such as pharmaceuticals and healthcare, comply with regulatory requirements for data integrity, particularly those involving CSV (Computer System Validation) processes. They assess, document, and test systems that handle data in CSV format to ensure accuracy, reliability, and compliance with standards like FDA 21 CFR Part 11. Their role includes developing validation protocols, performing risk assessments, and supporting audits. They help organizations avoid costly compliance issues and ensure the integrity of electronic records.

What are the key skills and qualifications needed to thrive as a CSV Validation Consultant, and why are they important?

To thrive as a CSV Validation Consultant, you need expertise in computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or IT. Familiarity with validation documentation tools, risk assessment methodologies, and industry standards like GAMP 5 is typically required. Strong analytical skills, attention to detail, and effective communication are essential soft skills for managing complex validation projects and collaborating with cross-functional teams. These abilities ensure that computer systems are compliant, reliable, and meet quality standards critical to regulated industries.

What are some typical challenges a CSV Validation Consultant faces when working on multiple projects simultaneously?

CSV Validation Consultants often manage several validation projects at once, each with its own regulatory requirements and timelines. Balancing these can be challenging, as it requires excellent organizational skills, prioritization, and clear communication with stakeholders to ensure deliverables are met without compromising quality. Consultants must also stay updated on evolving compliance standards and collaborate closely with QA teams, IT, and system owners to address issues promptly and maintain documentation accuracy across all projects.

What is the difference between Csv Validation Consultant vs Data Analyst?

AspectCsv Validation ConsultantData Analyst
CertificationsData validation, quality assurance certificationsData analysis, statistical certifications
Work EnvironmentData validation projects, quality assurance teamsData interpretation, reporting, business insights
Industry UsageData management, compliance, data integrity rolesBusiness intelligence, market research, reporting

The Csv Validation Consultant primarily focuses on ensuring data accuracy and integrity through validation processes, often working within quality assurance teams. In contrast, a Data Analyst interprets data to generate insights and support decision-making. While both roles handle data, their core responsibilities and work environments differ significantly.

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

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

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

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

What cities in Puerto Rico are hiring for Csv Validation Consultant jobs?

Cities in Puerto Rico with the most Csv Validation Consultant job openings:

Csv Validation Consultant jobs near you

CSV Specialist

Mirus Consulting Group

Gurabo, PR • On-site

$60 - $80/hr

Other

Re-posted 23 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.

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