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Computer System Validation Csv Pharmaceutical Jobs in Puerto Rico

CIS International LLC

PR · On-site

... pharmaceutical manufacturing industry in Puerto Rico. Responsibilities: * Provide technical leadership for commissioning, qualification, and computer system validation activities, including:

Validation & Engineering Group, Inc

PR · On-site

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

Validation & Engineering Group, Inc

PR

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

Validation & Engineering Group, Inc

PR · On-site

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

Validation & Engineering Group, Inc

PR

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

Validation & Engineering Group, Inc

PR · On-site

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

CIS International LLC

PR

... pharmaceutical manufacturing industry in Puerto Rico. Responsibilities: * Provide technical leadership for commissioning, qualification, and computer system validation activities, including:

JC Automation Corp

PR · On-site

Support execution of the Computer System Validation (CSV) lifecycle, including requirements ... Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments ...

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.

Cencora

Sr. Automation Engineer

Juncos, PR

$101K - $132K/yr

  • Medical

  • Dental

  • Vision

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 ...

Mentor Technical Group

Sr. C&Q Specialist

Juncos, PR · On-site

More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)

Validation & Engineering Group, Inc

PR

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

Validation & Engineering Group, Inc

PR

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

New

JC Automation Corp

PR · On-site

$25 - $45/hr

Working knowledge of GMP, validation lifecycle, and pharmaceutical regulatory expectations * Hands-on execution of IQ, OQ, and PQ protocols for manufacturing and utility systems * C&Q documentation ...

Mirus Consulting Group

Engineer - 35631

Juncos, PR · On-site

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 ...

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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 76% Full Time, and 24% Contract. Highlights an 100% In-person job distribution.

Qualification & Validation Engineer II - capital projects

CIS International LLC

PR • On-site

Full-time, Contractor

Posted 18 days ago

Job description

Summary:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
  • Provide technical leadership for commissioning, qualification, and computer system validation activities, including:
    • Leading and executing end-to-end qualification and lifecycle management of facilities, utilities, manufacturing equipment, process systems, and computerized systems.
    • Planning, coordinating, and delivering qualification and validation project milestones within scope, timeline, and budget constraints.
    • Developing, reviewing, approving, and executing validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and summary reports.
    • Directing protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
    • Monitoring, tracking, and communicating validation project status, risks, and deliverables to project teams and leadership.
  • Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and protocol designs based on risk management principles, process understanding, and industry best practices.
  • Evaluate and document the impact of change controls on qualified systems, validated processes, facilities, utilities, and computerized systems, ensuring compliance with site and regulatory requirements.
  • Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
  • Develop, implement, and continuously improve validation procedures, standards, policies, and lifecycle management practices aligned with regulatory expectations and industry trends.
  • Maintain compliance with current global regulatory requirements and industry guidance, including but not limited to:
    • 21 CFR Parts 210, 211, and 11
    • EU GMP Annex 11 and Annex 15
    • ICH Q8, Q9, and Q10
    • ISPE Baseline Guides and GAMP 5
    • Applicable domestic and international regulatory standards
  • Manage multiple high-priority projects simultaneously, balancing competing demands while consistently meeting aggressive timelines and business objectives.
  • Perform other duties and special projects as assigned.
Requirements:
  • Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
  • 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
Work Methodology:
  • Professional services agreement (independent contractor)
  • Full time job
  • Full on site job in Vega Baja, Puerto Rico
  • Languages: Spanish and English
  • Type of industry: Pharmaceutical
  • Expected hiring date:  August 2026
  • Project term: 6-12 months with potential extensions
  • Amount of openings: 4
  • Administrative shift, wiling to support non-admin hours