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Senior Computer System Validation Csv Jobs in Puerto Rico

Validation & Engineering Group, Inc

PR

$57K - $58K/yr

Associate CSV - Periodic Review Scientist Position Summary The Associate CSV Periodic Review ... computer systems to ensure compliance with regulatory requirements and maintenance of the validated ...

Jj

Global Automation Sr Principal Engineer

Gurabo, PR

$100K - $131K/yr

As the GET, Automation Senior Principal Engineer, they will lead early design inputsto process ... Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including ...

Validation & Engineering Group, Inc

PR

$59K - $60K/yr

Associate CSV - Periodic Review Scientist Position Summary The Associate CSV Periodic Review ... computer systems to ensure compliance with regulatory requirements and maintenance of the validated ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR · On-site

$101K - $139K/yr

The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor ... Position Overview The Senior Engineer will provide technical leadership and hands-on engineering ...

Validation & Engineering Group, Inc

PR

... senior management of quality, compliance, supply, and safety risks. • Provide support and ... systems validation (CSV) or computer systems quality assurance, including consulting level ...

JC Automation Corp

$80K - $105K/yr

MES software migration and Computer System Validation (CSV) lifecycle * cGMP, 21 CFR Part 11, and Data Integrity compliance for electronic systems * C&Q RFP development and vendor management * Change ...

JC Automation Corp

PR · On-site

$18 - $25/hr

Knowledge of Computer System Validation (CSV) requirements and documentation. * Prior experience with system administration tasks for GxP computerized systems. * Familiarity with CMMS tools for ...

Mirus Consulting Group

Project Manager

Manati, PR · On-site

The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

Validation & Engineering Group, Inc

PR

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

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Senior Computer System Validation Csv information

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you

Packaging Project Manager

Mirus Consulting Group

Gurabo, PR • On-site

Other

Posted 10 days ago

Job description

mirus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its services include theassessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensiveproject management supportto ensure compliance, efficiency, and operational excellence.Key Responsibilities

  • Lead end-to-end execution of packaging-related projects, including planning, scheduling, budgeting, coordination, and implementation.

  • Coordinate activities across Packaging Operations, Engineering, Validation (CSV/CQV), Automation, Manufacturing, and Facilities to ensure successful project execution.

  • Manage packaging equipment installation, upgrades, modifications, integration, and startup activities.

  • Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation strategies for packaging initiatives.

  • Ensure compliance with cGMP regulations, safety requirements, internal procedures, and quality standards throughout all project phases.

  • Oversee commissioning, qualification, and validation activities (IQ/OQ/PQ) associated with packaging equipment and systems.

  • Coordinate change control activities, impact assessments, technical documentation, and implementation plans.

  • Support packaging process improvements, operational readiness activities, and efficiency initiatives.

  • Serve as the primary point of contact between clients, vendors, contractors, and cross-functional internal teams.

  • Monitor project performance, budgets, deliverables, and KPIs while providing regular project status updates to leadership.

  • Identify and resolve project risks, operational challenges, scheduling conflicts, and resource constraints.

  • Support audits, inspections, and maintain projects in a state of compliance and inspection readiness.

Minimum Qualifications

  • Bachelor's Degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related discipline required).

  • Minimum of 5+ years of project management experience within pharmaceutical, biotechnology, or medical device industries.

  • Proven experience supporting packaging operations, packaging equipment, serialization, labeling systems, inspection systems, or manufacturing support projects.

  • Strong knowledge of cGMP regulations and pharmaceutical packaging operations.

  • Hands-on experience with Commissioning, Qualification, and Validation (CQV) activities related to packaging systems and equipment.

  • Experience managing Change Control systems within regulated manufacturing environments.

  • Experience coordinating vendors, contractors, packaging equipment manufacturers, and cross-functional project teams.

  • Strong leadership, organizational, communication, and problem-solving skills.

  • Bilingual communication skills (English and Spanish preferred).

  • Proficiency in MS Office applications including Word, Excel, PowerPoint, and Microsoft Project.

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.

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