The role involves leading end-to-end Computer System Validation activities, ensuring compliance ... Responsibilities : • Lead and execute end-to-end CSV activities across the validation lifecycle ...
The role involves leading end-to-end Computer System Validation activities, ensuring compliance ... Responsibilities : • Lead and execute end-to-end CSV activities across the validation lifecycle ...
Computer System Validation Lead
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
Computer System Validation Lead
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... ALCOA+ data integrity principles. • Experience validating SDLC/CSV across system types (e.g ...
Quick apply
COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... ALCOA+ data integrity principles. • Experience validating SDLC/CSV across system types (e.g ...
CSV Specialist II
Newark, DE · On-site
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
CSV Specialist II
Newark, DE · On-site
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
CSV Specialist II
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
CSV Specialist II
$95K - $105K/yr
Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and regulatory requirements * Strong shopfloor process knowledge required, experience in pharma ...
GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and regulatory requirements * Strong shopfloor process knowledge required, experience in pharma ...
GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and regulatory requirements * Strong shopfloor process knowledge required, experience in pharma ...
GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and regulatory requirements * Strong shopfloor process knowledge required, experience in pharma ...
CSV Lead
Wilmington, DE · On-site
... in Computer Science, Information Technology, or related discipline • Minimum 10+ years of experience in the Information Technology field • 5+ years of pharmaceutical GxP system validation ...
CSV Lead
Wilmington, DE · On-site
... in Computer Science, Information Technology, or related discipline • Minimum 10+ years of experience in the Information Technology field • 5+ years of pharmaceutical GxP system validation ...
Freelance Art Handler, Crozier
New Castle, DE · On-site
$20/hr
Spend a small amount of time (approximately 5%) on a laptop/desktop computer or telephone to manage ... Valid driver's license and willingness to travel to regional locations for onsite work. * Physical ...
Freelance Art Handler, Crozier
New Castle, DE · On-site
$20/hr
Spend a small amount of time (approximately 5%) on a laptop/desktop computer or telephone to manage ... Valid driver's license and willingness to travel to regional locations for onsite work. * Physical ...
... validation to include advanced joins • Perform complex programming functions, assistance, and ... of agency computer systems as assigned. • Create new and update existing Rhapsody routes to ...
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... validation to include advanced joins • Perform complex programming functions, assistance, and ... of agency computer systems as assigned. • Create new and update existing Rhapsody routes to ...
Lottery Security/Operations Specialist I
Dover, DE · On-site
$20/hr
... computer systems and data networks. * Six months' experience in researching and analyzing data, interpreting information, providing direction and guidance and/or instruction. * Possession of a valid ...
Lottery Security/Operations Specialist I
Dover, DE · On-site
$20/hr
... computer systems and data networks. * Six months' experience in researching and analyzing data, interpreting information, providing direction and guidance and/or instruction. * Possession of a valid ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Document all changes made to validated control systems as required by SOPs in SAP and MDT * Prepare ... Strong background in mathematics and computer applications to include database management software ...
Product Specialist
Dover, DE · On-site
... Basic understanding of computer systems, networks, and common software applications. • Strong ... • Valid driver's license may be required for travel between agency locations. • Must ...
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Product Specialist
Dover, DE · On-site
... Basic understanding of computer systems, networks, and common software applications. • Strong ... • Valid driver's license may be required for travel between agency locations. • Must ...
... computer system.\r\n Ensures system and facility security for Lottery drawings; ensures drawing ... valid Driver's License (not suspended, revoked, or cancelled, or disqualified from driving).\r\n\r ...
... computer system.\r\n Ensures system and facility security for Lottery drawings; ensures drawing ... valid Driver's License (not suspended, revoked, or cancelled, or disqualified from driving).\r\n\r ...
Photographer
Newark, DE · On-site
$17/hr
Have a Valid Drivers License and own vehicle * Excellent computer skills including email and ... Paid Training * Full time, seasonal position leaving time for freelance work. Photography ...
Photographer
Newark, DE · On-site
$17/hr
Have a Valid Drivers License and own vehicle * Excellent computer skills including email and ... Paid Training * Full time, seasonal position leaving time for freelance work. Photography ...
Photographer
Newark, DE · On-site
$17/hr
Have a Valid Drivers License and own vehicle * Excellent computer skills including email and ... Paid Training * Full time, seasonal position leaving time for freelance work. Photography ...
Photographer
Newark, DE · On-site
$17/hr
Have a Valid Drivers License and own vehicle * Excellent computer skills including email and ... Paid Training * Full time, seasonal position leaving time for freelance work. Photography ...
Freelance Art Handler, Crozier
New Castle, DE · On-site
$20/hr
Spend a small amount of time (approximately 5%) on a laptop/desktop computer or telephone to manage ... Valid driver's license and willingness to travel to regional locations for onsite work. * Physical ...
Freelance Art Handler, Crozier
New Castle, DE · On-site
$20/hr
Spend a small amount of time (approximately 5%) on a laptop/desktop computer or telephone to manage ... Valid driver's license and willingness to travel to regional locations for onsite work. * Physical ...
Basic understanding of computer systems, networking, and common software tools. * Strong problem ... Valid driver's license may be required. * Ability to pass a comprehensive background check.
Quick apply
Basic understanding of computer systems, networking, and common software tools. * Strong problem ... Valid driver's license may be required. * Ability to pass a comprehensive background check.
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 Delaware? The most popular types of Computer System Validation Csv jobs in Delaware are:
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Full-time
Posted 2 days ago
Tata Consultancy Services rating
6.5
Based on 21 frontline employees who took The Breakroom Quiz
159th of 210 rated it services
Job description
Job Summary:
Tata Consultancy Services is a prominent technology company, and they are seeking a Computer System Validation Lead. The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments.
Responsibilities:
• Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.
Qualifications:
Required:
• 8–10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills.
Company:
Tata Consultancy Services is a business solutions company that specializes on information technology services and consulting. It is a sub-organization of Tata Group. Founded in 1968, the company is headquartered in Mumbai, IND, with a team of 10001+ employees. The company is currently Late Stage.
Tata Consultancy Services is a prominent technology company, and they are seeking a Computer System Validation Lead. The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments.
Responsibilities:
• Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.
Qualifications:
Required:
• 8–10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills.
Company:
Tata Consultancy Services is a business solutions company that specializes on information technology services and consulting. It is a sub-organization of Tata Group. Founded in 1968, the company is headquartered in Mumbai, IND, with a team of 10001+ employees. The company is currently Late Stage.
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About Tata Consultancy Services
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Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering, and assurance services. This is delivered through its unique Global Network Delivery Model™, recognized as the benchmark of excellence in software development. TCS delivers a level of certainty that no other firm can match--to our clients and to our employees. Come join us and experience certainty in your career. TCS a global Consulting and IT Services firm that is ranked in the top quartile by industry analysts. Our 2021 fiscal revenues topped $25 B and our market capitalization is over $170+B, yet we have a deep and large history of philanthropy and corporate social responsibility. Now approaching 600K of the best IT professionals and consultants, we are a trusted advisor, guiding our clients' enterprises through growth and transformation journeys - helping them to become agile, intelligent, automated and on the cloud. We are devoted to DEI and are recognized as a top employer and place to work.