1

Csv Validation Consultant Jobs in Puerto Rico (NOW HIRING)

QA Specialist- ProQN669

Juncos, PR · On-site

$60 - $80/hr

... validation (CSV) or computer systems quality assurance (CSA/CSQA), particularly within regulated environments. * Experience supporting medical device environments and/or consulting projects. * Strong ...

Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency. * Experience with validation of GxP applications, including ...

Sr. Automation Engineer

Juncos, PR · On-site

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT ... Echo Consulting Group Inc

Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency. Experience with validation of GxP applications, including ...

Showing results 21-28

Csv Validation Consultant information

What does a CSV Validation Consultant do?

A CSV Validation Consultant specializes in ensuring that computer systems used in regulated industries, such as pharmaceuticals and healthcare, comply with regulatory requirements for data integrity, particularly those involving CSV (Computer System Validation) processes. They assess, document, and test systems that handle data in CSV format to ensure accuracy, reliability, and compliance with standards like FDA 21 CFR Part 11. Their role includes developing validation protocols, performing risk assessments, and supporting audits. They help organizations avoid costly compliance issues and ensure the integrity of electronic records.

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

To thrive as a CSV Validation Consultant, you need expertise in computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or IT. Familiarity with validation documentation tools, risk assessment methodologies, and industry standards like GAMP 5 is typically required. Strong analytical skills, attention to detail, and effective communication are essential soft skills for managing complex validation projects and collaborating with cross-functional teams. These abilities ensure that computer systems are compliant, reliable, and meet quality standards critical to regulated industries.

What are some typical challenges a CSV Validation Consultant faces when working on multiple projects simultaneously?

CSV Validation Consultants often manage several validation projects at once, each with its own regulatory requirements and timelines. Balancing these can be challenging, as it requires excellent organizational skills, prioritization, and clear communication with stakeholders to ensure deliverables are met without compromising quality. Consultants must also stay updated on evolving compliance standards and collaborate closely with QA teams, IT, and system owners to address issues promptly and maintain documentation accuracy across all projects.

What is the difference between Csv Validation Consultant vs Data Analyst?

AspectCsv Validation ConsultantData Analyst
CertificationsData validation, quality assurance certificationsData analysis, statistical certifications
Work EnvironmentData validation projects, quality assurance teamsData interpretation, reporting, business insights
Industry UsageData management, compliance, data integrity rolesBusiness intelligence, market research, reporting

The Csv Validation Consultant primarily focuses on ensuring data accuracy and integrity through validation processes, often working within quality assurance teams. In contrast, a Data Analyst interprets data to generate insights and support decision-making. While both roles handle data, their core responsibilities and work environments differ significantly.

What are popular job titles related to Csv Validation Consultant jobs in Puerto Rico?

For Csv Validation Consultant jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Csv Validation Consultant jobs in Puerto Rico look for?

The top searched job categories for Csv Validation Consultant jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Csv Validation Consultant jobs?

Cities in Puerto Rico with the most Csv Validation Consultant job openings:

Manufacturing Engineer II

Echo-Consulting-Group

Villalba, PR • On-site

$60 - $80/hr

Other

Posted 21 days ago


Key responsibilities

  • Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.

  • Inspects the performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.


Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Responsibilities:
  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.
Shift

1st Shift, 2nd Shift

Location

Villalba, PR

Education

Bachelor’s degree in Engineering.

Preferred Qualifications:
  • Change control of Medical Devices
  • Equipment Commissioning / Qualification
  • Process Validation 4. Computer System Validation (CSV)
  • Manufacturing, Packaging and Laboratory Equipment
  • Technical experience (Trouble shooting) or any similar experience or background
  • Quality / Process Control / Assurance of Medical Devices
Skills:
  • Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.

#J-18808-Ljbffr