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Freelance Computer System Validation Csv Jobs in Puerto Rico

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

PR · On-site

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

CSV Lead

Carolina, PR

$90K - $118K/yr

The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is ...

PR · On-site

$35 - $45/hr

You will also ensure full compliance with cGMP, FDA regulations, and the Computer System Validation (CSV) lifecycle throughout all project phases. RESPONSIBILITIES * Capital Project Leadership: Lead ...

PR · On-site

$40 - $50/hr

CSV Lifecycle Management: Ensure the full Computer System Validation lifecycle is executed in compliance with cGMP, FDA regulations, and 21 CFR Part 11, including documentation development, protocol ...

Perform Computerized System Validation (CSV) activities following site CSV Standard Procedure ... Bachelor's Degree in Engineering or Computer Science combined with three (3) years of CSV and ...

PR · On-site

$25 - $30/hr

Author and execute validation documentation including IQ/OQ, TMX, and QRS protocols; support Computer System Validation (CSV) deliverables using Kneat Software; and resolve findings related to ...

MES Project Manager

Manati, PR

$83K - $98K/yr

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.

MES Project Manager

Manati, PR

$83K - $98K/yr

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.

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 ...

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 ...

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Freelance Computer System Validation Csv information

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

A Freelance Computer System Validation (CSV) specialist is an independent professional who ensures that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulatory requirements. CSV specialists test and document that software and hardware systems function as intended, are reliable, and meet compliance guidelines like FDA 21 CFR Part 11 or EU Annex 11. As freelancers, they work on a contract basis, often supporting multiple clients, and may help design validation strategies, conduct risk assessments, and prepare necessary documentation for audits and inspections.

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

To thrive as a Freelance Computer System Validation (CSV) specialist, you need expertise in regulatory compliance (such as FDA 21 CFR Part 11), validation protocols, and risk-based validation methodologies, often supported by a degree in life sciences, engineering, or IT. Familiarity with industry-standard validation tools, software testing platforms, and knowledge of GxP systems as well as certifications like PMP or GAMP are commonly required. Strong project management, analytical thinking, and effective communication skills set top performers apart in client-facing freelance environments. These competencies are crucial for ensuring validated systems meet strict regulatory requirements while efficiently managing projects and client expectations.

What are some common challenges faced by freelance Computer System Validation (CSV) specialists, and how can they effectively overcome them?

Freelance CSV specialists often encounter challenges such as adapting to diverse client systems, staying updated with evolving regulatory requirements, and managing multiple projects simultaneously. To overcome these, it's important to maintain strong communication with client teams, invest in ongoing professional development, and utilize project management tools to keep workflows organized. Additionally, building a network with other CSV professionals can provide valuable support and industry insights.
What are the most commonly searched types of Computer System Validation Csv jobs in Puerto Rico? The most popular types of Computer System Validation Csv jobs in Puerto Rico are:
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Computer System Validation (CSV) Specialist

Computer System Validation (CSV) Specialist

Cencora

Carolina, PR • On-site

Full-time

Medical, Dental, Vision

Posted 4 days ago


Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Summary of Role:

Responsible for the MES Support and validation services. Primary focused on Syncade recipe configuration and validation. For this opportunity the resource will be working collaboratively with cross-functional teams including Manufacturing, Quality, Automation, and IT to ensure systems are configured, tested, and maintained in compliance with GMP and Computer System Validation (CSV) requirements.

Responsibilities:

  • Supporting Syncade recipe configuration and maintenance, version control, and lifecycle management (e.g., Recipe Authoring, Equipment Tracking, Material Management, Workflow, Inventory)
  • Configure and maintain MES modules and workflows, ensuring alignment with site and global standards.
  • Configure and support MES integrations with ERP and automation systems (e.g., SAP, DCS, middleware).
  • Provide configuration-level troubleshooting and support root cause analysis for MES-related issues.
  • Execute and support CSV deliverables associated with Syncade configuration changes, including but not limited to: Risk assessments, URS / FRS reviews, test plans and test scripts, and IQ / OQ / PQ execution and summary reports.
  • Prepare and ensure validation documentation complies with GMP, CSV, and ALCOA+ data integrity principles.
  • Support change control impact assessments, deviations, and CAPA activities related to MES.
  • Support data validation and reconciliation activities for MES-related reports.
  • Participate in project meetings, design reviews, and deployment activities.

Shift: Administrative (Available to work or provide support to a 24/7 manufacturing operation, as required)

Location: Carolina, PR

Education: Bachelor's degree in Science or Engineering

Preferred Qualifications:

  • 5+ years of experience in CSV in regulated environments
  • 3+ years of hands-on experience with MES platforms, preferably Emerson Syncade, including development and maintenance of BI solutions.
  • Computer systems integrations and validation experience in regulated operations (preferably GMP operations).
  • Strong experience authoring and executing validation documentation (test scripts, protocols, reports).
  • Excellent technical and quality documentation skills in English, including validation deliverables and test evidence.
  • Able to use a logical, systematic approach to problem solving.
  • Ability to manage multiple priorities and work independently with limited supervision.
  • Strong communication, teamwork and collaboration skills.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full timeEqual Employment Opportunity

Cencora 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.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc