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Computer System Validation Csv Pharmaceutical Jobs in Puerto Rico

Veg Group

Specialist QA (5:00 pm - 5:30 am)

Juncos, PR · On-site

$80 - $100/hr

Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

PACIV

IT / CSV Specialist

San Juan, PR · On-site

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

Pinnaql

Specialist QA (5:00 pm - 5:30 am)

Juncos, PR · On-site

Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

Pinnaql

C&Q Specialist

Humacao, PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Pinnaql

C&Q Specialist

Juncos, PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Pinnaql

C&Q Specialist

Humacao, PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Pinnaql

C&Q Specialist

Gurabo, PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Cencora

Sr. Automation Engineer

Juncos, PR · On-site

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

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Computer System Validation Csv Pharmaceutical information

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 are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Puerto Rico?

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

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Puerto Rico look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Puerto Rico with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.

Sr. CSV & (C&Q) Specialist

MENTOR Technical Group Corporation

Manati, PR • On-site

$80 - $100/hr

Other

Posted 6 days ago

Job description

Overview

Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.


Responsibilities

  • Support Commissioning and Qualification (C&Q) activities for plants and equipment.

  • Develop, review, and maintain commissioning and qualification procedures and documentation.

  • Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and lab equipment.

  • Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.

  • Manage change controls and deviations related to plants and equipment.

  • Support maintenance and calibration functions to improve compliance and quality.

  • Provide expertise in troubleshooting and root cause investigations.

  • Facilitate the transfer of technical knowledge across units and sites.


Qualifications / Requirements / Knowledge / Skills

  • Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.

  • Demonstrated experience in Commissioning and Qualification (C&Q) activities.

  • Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.

  • More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.

  • Experience with digital validation solutions (e.g., ALM or equivalent).

  • Excellent skills in writing validation, commissioning, and technical documentation in English.

  • Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).

  • Bilingual: fluent in English and Spanish.


Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.


Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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