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Computer System Validation Csv Remote Jobs in Indiana

Zifo

Veeva QMS Consultant

Bloomington, IN · On-site +1

**This role is open to remote candidates who have availability to travel to the client in Bloomington ... Computer Systems Validation is required for this role * Strong knowledge of GxP Requirements, GLP ...

Zifo

Veeva QMS Consultant

Bloomington, IN · On-site +1

**This role is open to remote candidates who have availability to travel to the client in Bloomington ... Computer Systems Validation is required for this role * Strong knowledge of GxP Requirements, GLP ...

S&S's Customer Information Systems

A valid passport is needed for travel About Systems & Software: Systems and Software (S&S), a ... Computer Systems, is a software development company headquartered in Winooski, VT, that was ...

Harris

A valid passport is needed for travel About Systems & Software: Systems and Software (S&S), a ... Computer Systems, is a software development company headquartered in Winooski, VT, that was ...

Harris

A valid passport is needed for travel About Systems & Software: Systems and Software (S&S), a ... Computer Systems, is a software development company headquartered in Winooski, VT, that was ...

Harris

Travel is required as needed, approximately 10%. Candidates must hold a current, valid passport and ... Bachelor's degree in Geographic Information Systems, Computer Science, Geography, or a related ...

Harris

Travel is required as needed, approximately 10%. Candidates must hold a current, valid passport and ... Bachelor's degree in Geographic Information Systems, Computer Science, Geography, or a related ...

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Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

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

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
What are the most commonly searched types of Computer System Validation Csv jobs in Indiana? The most popular types of Computer System Validation Csv jobs in Indiana are:
What are popular job titles related to Computer System Validation Csv Remote jobs in Indiana? For Computer System Validation Csv Remote jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Remote jobs in Indiana look for? The top searched job categories for Computer System Validation Csv Remote jobs in Indiana are:
What cities in Indiana are hiring for Computer System Validation Csv Remote jobs? Cities in Indiana with the most Computer System Validation Csv Remote job openings:
Computer System Validation Csv Remote jobs near you

Veeva QMS Consultant

Zifo

Bloomington, IN • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 23 days ago

Job description

**This role is open to remote candidates who have availability to travel to the client in Bloomington, IN on a regular basis**
Zifo is seeking a highly skilled and detail-oriented Veeva QMS consultant to support the implementation, optimization, and ongoing management of Quality Management Systems (QMS) within a regulated scientific environment. This role will focus on leveraging Veeva Vault QMS solutions to ensure compliance, streamline processes, and enhance operational efficiency across quality and regulatory functions.
The ideal candidate combines strong scientific domain knowledge with technical expertise in QMS platforms and Veeva Vault applications.
Responsibilities:
  • Lead the implementation, configuration, and support of QMS applications, with a focus on Veeva Vault QMS.
  • Collaborate with cross-functional stakeholders (Quality, Regulatory, R&D, IT) to gather requirements and translate them into system solutions.
  • Ensure compliance with industry regulations (e.g., GxP, FDA, ISO standards) through proper system design and usage.
  • Provide subject matter expertise on QMS processes including CAPA, Change Control, Deviations, Audits, and Document Management.
  • Configure and maintain Veeva Vault modules to support business processes and regulatory requirements.
  • Conduct system validation activities, including documentation, testing, and change control.
  • Support data migration, system upgrades, and integrations with other enterprise systems.
  • Deliver end-user training and provide ongoing support to ensure effective system adoption.
  • Identify opportunities for process improvement and system optimization.
  • Participate in audits and inspections, providing system-related support and documentation.

Requirements
  • QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent).
  • Veeva Certification, specifically related to Veeva Vault (QMS preferred).
  • Proven experience working with Quality Management Systems (QMS) in regulated environments.
  • Hands-on experience with Veeva Vault QMS, including configuration and administration.
  • Strong understanding of GxP compliance requirements and validation processes (CSV/CSA).
  • Experience with quality processes such as CAPA, Change Control, Deviations, and Audits.
  • Excellent analytical, problem-solving, and communication skills.

Qualifications
  • Bachelor or Master's degree in Life sciences or Computer Sciences
  • 5+ years' experience with Computer Systems Validation is required for this role
  • Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirements
  • QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent).
  • Veeva Certification, specifically related to Veeva Vault (QMS preferred).
  • Proven experience working with Quality Management Systems (QMS) in regulated environments.
  • Hands-on experience withVeeva Vault QMS, including configuration and administration.
  • Strong understanding of GxP compliance requirements and validation processes (CSV/CSA).
  • Experience with quality processes such as CAPA, Change Control, Deviations, and Audits.
  • Excellent analytical, problem-solving, and communication skills.

Benefits
CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies.
We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability.
We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
If you share these sentiments and are prepared for the atypical, then Zifo is your calling!
Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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