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Csv Validation Engineer Jobs in Bayamon, PR (NOW HIRING)

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 ...

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 ...

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

... Engineering, Operations, Quality, and external vendors. * Develop and review: * Validation Plans ... Develop CSV training plans and training matrices. * Monitor CSV milestones, schedules, and project ...

Manufacturing Engineer I

Villalba, PR · Remote

$74K - $96K/yr

Provides guidance to engineering regarding design concepts and specification requirements to best ... Highly desirable previous experience executing CSV validation of Equipment Controller in a ...

... and validation activities within a pharmaceutical manufacturing environment. Position ... Bachelor's degree in IT, Computer Science, Engineering, or a related field preferred.

Attend cross-functional meetings with Engineering, Quality, Validation, IT, and Manufacturing ... CSV, PQ), and close-out. * Support audits, deviations, and CAPAs as needed. * Occasionally work ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality ... We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services ...

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $117K/yr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality ... We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services ...

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Csv Validation Engineer information

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How much do csv validation engineer jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for csv validation engineer in Bayamon, PR is $46.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.53 and $56.92 per hour, depending on experience, location, and employer.

What is a CSV validation engineer?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV validation engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

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

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness 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.

What are popular job titles related to Csv Validation Engineer jobs in Bayamon, PR?

For Csv Validation Engineer jobs in Bayamon, PR, the most frequently searched job titles are:

What job categories do people searching Csv Validation Engineer jobs in Bayamon, PR look for?

The top searched job categories for Csv Validation Engineer jobs in Bayamon, PR are:

What cities near Bayamon, PR are hiring for Csv Validation Engineer jobs?

Cities near Bayamon, PR with the most Csv Validation Engineer job openings:

CSV Specialist

Mirus Consulting Group

Gurabo, PR • On-site

Full-time

Re-posted 8 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.