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Senior Csv Engineer Jobs in Puerto Rico (NOW HIRING)

Three Point Solutions

PR · On-site

$80 - $110/hr

Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 ... Oversee CSV, IQ/OQ/PQ validation * Ensure FDA, ISO 13485, GxP, 21 CFR Part 11 compliance * Support ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR · On-site

$101K - $139K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Position Overview The Senior Engineer will provide technical leadership and hands-on engineering ...

FITS LLC

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 ...

FITS LLC

Sr. Manufacturing Engineer II

Juncos, PR · On-site

$89K - $121K/yr

C&Q strategy, planning, and execution (IQ/OQ/PQ, CSV) * Packaging process design, optimization, and ... Develop engineering policies and procedures that affect multiple organizational units. * Supervise ...

Cencora

Sr. Automation Engineer

Juncos, PR

$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 ...

JC Automation Corp

PR · On-site

$48 - $60/hr

... engineering leadership for robotic and automated logistics systems. In this role, you will serve as ... Act as the senior technical authority for robotics/ASRS OEMs and integrators; shape scope and ...

Validation & Engineering Group, Inc

PR · On-site

... lead or senior engineer role. * Hands-on experience with BMS and automation platforms (e.g ... Experience in regulated environments (GMP, GxP), including validation (CSV), commissioning ...

Validation & Engineering Group, Inc

PR

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... senior management of quality, compliance, supply, and safety risks. • Provide support and ...

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Senior Csv Engineer information

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

To excel as a Senior CSV (Computer System Validation) Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11, GAMP 5), and a relevant engineering or scientific degree. Proficiency with validation lifecycle documentation, risk management tools, and quality management systems is typically required, as are certifications like PMP or Six Sigma. Strong analytical skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These skills are essential to maintaining regulatory standards, minimizing risks, and ensuring the integrity and reliability of computerized systems in regulated industries.

What is the difference between Senior Csv Engineer vs Data Engineer?

AspectSenior Csv EngineerData Engineer
Required CredentialsBachelor's in Computer Science, Data Science, or related field; experience with CSV processingBachelor's or higher in Computer Science, Data Engineering, or related; often includes knowledge of databases and ETL tools
Work EnvironmentData processing teams, analytics departments, data pipelines involving CSV filesData infrastructure teams, big data environments, cloud platforms, and data pipelines
Employer & Industry UsageTech companies, finance, healthcare, any industry handling large CSV datasetsTech firms, finance, e-commerce, and industries requiring large-scale data integration

The main difference is that a Senior Csv Engineer specializes in managing and optimizing CSV data workflows, while a Data Engineer has a broader role in designing and maintaining comprehensive data infrastructure, including databases, pipelines, and big data systems. Both roles require similar foundational skills but differ in scope and complexity.

What are Senior CSV Engineers?

Senior CSV Engineers are experienced professionals who specialize in Computer System Validation (CSV) within regulated industries such as pharmaceuticals, biotechnology, and medical devices. Their main responsibility is to ensure that computer systems used in these industries comply with regulatory standards and function as intended. They lead validation projects, develop validation protocols, conduct risk assessments, and work closely with IT and quality assurance teams. Senior CSV Engineers also provide guidance on regulatory requirements, troubleshoot validation issues, and help maintain audit-ready documentation.

What are common challenges faced by Senior CSV Engineers when ensuring regulatory compliance across multiple projects?

Senior CSV Engineers often encounter the challenge of managing varying compliance standards and documentation requirements across multiple projects, especially when working with global teams. Keeping up-to-date with evolving regulations (such as FDA 21 CFR Part 11 or EU Annex 11) and ensuring that validation activities are harmonized across different systems can be demanding. Strong project management skills, proactive communication with cross-functional stakeholders, and meticulous attention to detail are essential for overcoming these challenges and maintaining audit-ready documentation.
What are the most commonly searched types of Csv Engineer jobs in Puerto Rico? The most popular types of Csv Engineer jobs in Puerto Rico are:
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What cities in Puerto Rico are hiring for Senior Csv Engineer jobs? Cities in Puerto Rico with the most Senior Csv Engineer job openings:
Senior Csv Engineer jobs near you
Infographic showing various Senior Csv Engineer job openings in Puerto Rico as of June 2026, with employment types broken down into 89% Full Time, 7% Part Time, and 4% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution.
Sr. CSV Specialist/ Lab Equipment Qualification

Sr. CSV Specialist/ Lab Equipment Qualification

Mentor Technical Group

Manati, PR • On-site

Full-time

Posted 20 days ago

Job description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Professional Summary
Experienced professional in laboratory protocol review, document revision, and validation of laboratory computerized systems (CSV) and SOPs. Skilled in LIMS and Empower, with extensive experience in laboratory instrument performance qualification and method configuration. Knowledgeable in regulatory compliance, data integrity, and project management within pharmaceutical manufacturing environments.
Professional Experience & Skills
  • Review and revise laboratory protocols and related documents.
  • Provide CSV (Computerized System Validation) and SOP validation services for laboratory equipment.
  • Experienced in LIMS and Empower platforms.
  • Laboratory instrument performance qualification, execution, and method configuration.
  • Familiar with GAMP5 methodology for validations.
  • At least 3 years of experience with PLCs, industrial computers, or laboratory instrumentation systems.
  • Strong understanding of network communication protocols (e.g., TCP/IP).
  • Proficient in project management tools and Visio.
  • Skilled in writing validation, commissioning, and technical documentation in English using MS Office applications.
  • Bilingual: English and Spanish.
Education & Qualifications
  • BS or higher in Chemistry, Biology, Microbiology, Computer Science, Information Systems, Engineering, or a related discipline.
  • More than 5 years of experience validating laboratory computerized systems in a manufacturing environment.
  • Trained in validation methodologies, technologies, and process control computer systems.
  • Strong knowledge of cGMP, FDA 21 CFR Part 11, and Data Integrity regulations.
  • Knowledgeable in computerized data collection systems and laboratory databases.
  • Background in pharmaceutical product manufacturing.

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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