The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its ...
The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its ...
... computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency. • Experience with validation of GxP applications, including Validation ...
Quick apply
... computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency. • Experience with validation of GxP applications, including Validation ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...
Sr. CSV & (C&Q) Specialist
Manati, PR · On-site
More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent). * Excellent ...
Sr. CSV & (C&Q) Specialist
Manati, PR · On-site
More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent). * Excellent ...
mirus 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 is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...
Jr. Validation Specialist
Humacao, 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 ...
Jr. Validation Specialist
Humacao, 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 ...
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 ...
Quick apply
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 ...
Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment. * Strong stakeholder management ...
Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment. * Strong stakeholder management ...
Global Automation Sr Principal Engineer
$100K - $131K/yr
Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment. * Strong stakeholder management ...
Global Automation Sr Principal Engineer
$100K - $131K/yr
Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment. * Strong stakeholder management ...
Manufacturing Engineer II
Villalba, PR · On-site
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
Manufacturing Engineer II
Villalba, PR · On-site
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
Sr. Engineer
$101K - $139K/yr
The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its ...
Sr. Engineer
$101K - $139K/yr
The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its ...
Manufacturing Engineer II
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
Quick apply
Manufacturing Engineer II
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
Manufacturing Engineer II
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
Manufacturing Engineer II
$70K - $91K/yr
... called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV ... The majority of time is spent delivering R&D, systems or initiatives related to new technologies or ...
PR · On-site
$80K - $105K/yr
... systems, Computer Systems Validation (CSV), or related technologies is preferred. • Strong project planning and organizational skills. • Excellent communication and stakeholder management ...
New
Quick apply
PR · On-site
$80K - $105K/yr
... systems, Computer Systems Validation (CSV), or related technologies is preferred. • Strong project planning and organizational skills. • Excellent communication and stakeholder management ...
New
PR · On-site
$92K - $121K/yr
... systems, Computer Systems Validation (CSV), or related technologies is preferred. • Strong project planning and organizational skills. • Excellent communication and stakeholder management ...
New
Quick apply
PR · On-site
$92K - $121K/yr
... systems, Computer Systems Validation (CSV), or related technologies is preferred. • Strong project planning and organizational skills. • Excellent communication and stakeholder management ...
New
JT259 - MANUFACTURING ENGINEER II
Villalba, PR · On-site
$70K - $91K/yr
Computer and software validation CSV * SOP Development * Change control of Medical Devices * MES system * Shift: 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all ...
JT259 - MANUFACTURING ENGINEER II
Villalba, PR · On-site
$70K - $91K/yr
Computer and software validation CSV * SOP Development * Change control of Medical Devices * MES system * Shift: 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all ...
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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Other
Posted 15 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.
Position Summary
The Project Manager lead the Incoming & MRO RePurpose project, involving the conversion of an existing laboratory building envelope into warehouse storage space. The Project Manager will be responsible for managing design, construction, and C&Q activities, ensuring successful execution within scope, schedule, and budget in a regulated environment.
Key Responsibilities
Position Summary
The Project Manager lead the Incoming & MRO RePurpose project, involving the conversion of an existing laboratory building envelope into warehouse storage space. The Project Manager will be responsible for managing design, construction, and C&Q activities, ensuring successful execution within scope, schedule, and budget in a regulated environment.
Key Responsibilities
- Lead and manage design management activities for facility repurpose
- Develop Construction and C&Q RFPs
- Manage end-to-end construction implementation
- Lead weekly construction meetings and site coordination meetings
- Lead weekly stakeholder meetings
- Manage and maintain RFI, submittal, and change order logs
- Lead and enforce the change control process
- Develop, track, and update project cash flow
- Develop and maintain the integrated project schedule
- Coordinate contractors, vendors, and internal stakeholders
- Ensure compliance with safety, quality, and GMP requirements
- Prepare project status reports and escalate risks as needed
- Support additional capital projects as required
- Bachelor's degree in Engineering, Construction Management, or related field
- Project Management experience in regulated industries (Pharma, Biotech, Life Sciences)
- Proven experience managing facility modifications or capital projects
- Working knowledge of C&Q processes
- Experience managing construction vendors and contractors
- Strong scheduling, financial management, and reporting skills
- Proficiency with MS Project or equivalent project management tools