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Csv Validation Engineer Jobs in Puerto Rico (NOW HIRING)

Weil Group, Inc

Manufacturing Engineer II

Villalba, PR · On-site

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Education Required: Bachelor's degree required in Engineering Years' Experience Required: Minimum of ...

Weil Group, Inc

Manufacturing Engineer II

Villalba, PR · On-site

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Education Required: Bachelor's degree required in Engineering Years' Experience Required: Minimum of ...

Weil Group, Inc.

Manufacturing Engineer II

Villalba, PR · On-site

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Education Required: Bachelor's degree required in Engineering Years' Experience Required: Minimum of ...

PACIV

Senior Automation Technician

San Juan, PR · On-site

$102K - $133K/yr

Bachelor's degree in Engineering (Electrical, Computer, Mechanical) or equivalent experience ... Experience supporting automation system validation (CSV) and documentation tools such as Kneat.

FITS LLC

C&Q Lead

Gurabo, PR · On-site

$98K - $130K/yr

For Validation and Commissioning & Qualification support in the Engineering area. WHAT MAKES YOU A ... CSV provider, Vendors, Client USERs). * Management and Filing of CQV related documentation.

JC Automation Corp

PR · On-site

$18/hr

Engineering Project Support: Assist in the management and execution of assigned engineering projects, including automation implementations and computer system validation (CSV) activities, under the ...

JC Automation Corp

PR · On-site

$18/hr

Engineering Project Support: Assist in the management and execution of assigned engineering projects, including automation implementations and computer system validation (CSV) activities, under the ...

JC Automation Corp

PR · On-site

$18/hr

Engineering Project Support: Assist in the management and execution of assigned engineering projects, including automation implementations and computer system validation (CSV) activities, under the ...

JC Automation Corp

PR · On-site

$18/hr

Engineering Project Support: Assist in the management and execution of assigned engineering projects, including automation implementations and computer system validation (CSV) activities, under the ...

Jj

Global Automation Sr Principal Engineer

Gurabo, PR

$100K - $131K/yr

Supply Chain Engineering Job Sub Function: Automation Engineering Job Category: Scientific ... Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including ...

Mirus Consulting Group

MES Project Manager

Manati, PR

$83K - $98K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Lead technical meetings with stakeholders and Syncade software developers * Coordinate system ...

Mirus Consulting Group

MES Project Manager

Manati, PR

$83K - $98K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Lead technical meetings with stakeholders and Syncade software developers * Coordinate system ...

Mirus Consulting Group

Project Manager

Manati, PR

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Bachelor's degree in Engineering, Construction Management, or related field * Project Management ...

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Csv Validation Engineer information

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

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What are Csv Validation Engineers?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV Validation Engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

What are popular job titles related to Csv Validation Engineer jobs in Puerto Rico? For Csv Validation Engineer jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Csv Validation Engineer jobs in Puerto Rico look for? The top searched job categories for Csv Validation Engineer jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Csv Validation Engineer jobs? Cities in Puerto Rico with the most Csv Validation Engineer job openings:
Csv Validation Engineer jobs near you

Packaging Project Manager

Mirus Consulting Group

Gurabo, PR

Full-time

Posted 16 days ago

Job description

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to 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.