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Computer System Validation Csv Pharmaceutical Jobs in Puerto Rico

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 ...

Mirus Consulting Group

Sr Engineer - 35627

Juncos, PR · On-site

$101K - $139K/yr

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 ...

New

Mirus Consulting Group

Sr Engineer - 35627

Juncos, PR · On-site

$101K - $139K/yr

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 ...

New

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR · On-site

$101K - $139K/yr

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 ...

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR · On-site

$101K - $139K/yr

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 ...

Mirus Consulting Group

Sr Engineer - 35409

Juncos, PR · On-site

$101K - $139K/yr

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 ...

Mirus Consulting Group

Sr Engineer - 35409

Juncos, PR · On-site

$101K - $139K/yr

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 ...

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.

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 · 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 · 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 · 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 · On-site

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

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All JobsComputer System Validation Csv Pharmaceutical JobsComputer System Validation Csv Pharmaceutical Jobs in Puerto Rico

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.

Engineer - 35631

Mirus Consulting Group

Juncos, PR • On-site

Full-time

Posted 5 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
We are seeking a highly motivated Engineer to support biotechnology manufacturing operations with a focus on downstream purification processes. The successful candidate will provide technical expertise, troubleshooting support, process monitoring, and continuous improvement initiatives within a GMP-regulated manufacturing environment.
Key Responsibilities
  • Provide engineering support for biotechnology manufacturing processes, specifically purification operations.
  • Monitor and optimize downstream processes to ensure product quality, process efficiency, and regulatory compliance.
  • Support the operation, troubleshooting, and performance improvement of chromatography and ultrafiltration/diafiltration (UF/DF) systems.
  • Analyze process data and identify opportunities for process optimization and operational excellence.
  • Support deviation investigations, root cause analyses, CAPAs, and change control activities as required.
  • Collaborate with Manufacturing, Quality, Validation, Maintenance, and Technical Services teams to resolve process issues.
  • Support equipment qualifications, process validations, and technology transfer activities as required.
  • Ensure compliance with GMP, safety, environmental, and company requirements.
  • Develop and revise technical documents, standard operating procedures (SOPs), and engineering reports.
Qualifications
  • Master’s Degree in Engineering; OR
  • Bachelor’s Degree in Engineering and 2 years of engineering experience.
  • Experience supporting biotechnology manufacturing processes, specifically purification operations.
  • Working knowledge of chromatography systems and techniques.
  • Experience with Ultrafiltration/Diafiltration (UF/DF) operations.
  • Familiarity with GMP-regulated environments and pharmaceutical or biotechnology manufacturing.
  • Strong problem-solving, analytical, and troubleshooting skills.
  • Ability to work effectively in a cross-functional team environment.
  • Excellent written and verbal communication skills.
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.