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Computer System Validation Csv Pharmaceutical Jobs in Bayamon, PR

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

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

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

$60 - $80/hr

... computer system validation and information technology consulting services to pharmaceutical ... 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

Significant experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other FDA-regulated environments. * Experience leading CSV activities on capital projects. * Strong ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$80 - $100/hr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality ... providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $116K/yr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality ... providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch ...

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Computer System Validation Csv Pharmaceutical information

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for computer system validation csv pharmaceutical in Bayamon, PR is $48.93, according to ZipRecruiter salary data. Most workers in this role earn between $37.69 and $58.03 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Bayamon, PR are:

What cities near Bayamon, PR are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities near Bayamon, PR with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

CSV Specialist

Mirus Consulting Group

Gurabo, PR • On-site

Full-time

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.
www.miruspr.com

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