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Computer System Validation Csv Pharmaceutical Jobs in Iowa

Elanco

Snr Analyst - TechOps IT

Fort Dodge, IA · On-site

... computer system validation (CSV), break-fix support, and release management. • Guide and manage multiple IT/OT projects simultaneously, developing project plans, managing budgets and schedules, and ...

Elanco

Snr Analyst - TechOps IT

Fort Dodge, IA

Take full ownership of the application lifecycle for local OT/IT systems, including solution development, vendor management, computer system validation (CSV), break-fix support, and release ...

Deloitte

System Test and Validation Lead

Davenport, IA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Davenport, IA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Davenport, IA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

UnityPoint Health

Pharmacist

Sioux City, IA

$57.75 - $69.25/hr

Enters TPN orders into compounder computer system accurately and timely. Education: * Graduate of ... Valid driver's license when driving any vehicle for work-related reasons required.

UnityPoint Health

Pharmacist

Sioux City, IA · On-site

$57.75 - $69.25/hr

Enters TPN orders into compounder computer system accurately and timely. Qualifications Education ... Valid driver's license when driving any vehicle for work-related reasons required.

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Computer System Validation Csv Pharmaceutical information

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Iowa? For Computer System Validation Csv Pharmaceutical jobs in Iowa, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Iowa look for? The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Iowa are:
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Computer System Validation Csv Pharmaceutical jobs near you

Snr Analyst - TechOps IT

Elanco

Fort Dodge, IA • On-site

Full-time

Re-posted yesterday

Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

51st of 86 rated pharmaceutical

Job description

Job Summary:
Elanco is a global leader in animal health dedicated to innovation and delivering products and services to improve the lives of animals. They are seeking a Senior IT Analyst for Operational Technology and Lab-Applications to bridge the gap between global IT teams and operational technology at their manufacturing and R&D sites.
Responsibilities:
• Partner with key business customers in manufacturing and R&D to elicit, analyze, and translate business needs into detailed application and operational requirements.
• Take full ownership of the application lifecycle for local OT/IT systems, including solution development, vendor management, computer system validation (CSV), break-fix support, and release management.
• Guide and manage multiple IT/OT projects simultaneously, developing project plans, managing budgets and schedules, and communicating status to stakeholders to ensure successful delivery.
• Provide hands-on technical guidance for the integration and support of IT/OT solutions, performing complex troubleshooting of systems, infrastructure, and databases to ensure operational stability.
• Proactively network with IT and OT resources across Elanco to stay informed of company-wide initiatives, share reusable solutions, and capture and implement best practices to drive continuous improvement.
Qualifications:
Required:
• Education: Bachelor's Degree in Information Technology, Process Automation, Operational Technology, Engineering, or a related field; or equivalent experience in lieu of a degree.
• Experience: A minimum of 3 years of experience in Information Technology and 3 years of experience in Operational Technology infrastructure support.
• Critical Thinking & Innovation: Demonstrated creativity and alternative thinking to develop new ideas and solve work-related problems, using logic and reasoning to identify the strengths and weaknesses of alternative solutions.
• Interpersonal & Communication: Proven ability to establish and maintain constructive, cooperative working relationships across all levels of the organization and cultural boundaries. Prepares coherent, grammatically correct, and engaging written correspondence and delivers equally proficient oral presentations.
• Guidance & Self-Management: Proficient facilitation, and teamwork abilities, combined with the initiative to work independently, self-manage priorities, and handle multiple tasks effectively.
• Business & Safety Acumen: Knowledge of assigned business processes (lab, supply chain, quality, science, etc.) and a steadfast commitment to complying with all safety policies and regulations.
• Work Authorization: Must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Preferred:
• Previous experience in a Technology Integrator or Business Analyst role.
• Direct experience with Computer System Validation (CSV) and a proficient understanding of qualification processes and adherence to them.
• Proficiency with ITIL management tools (specifically ServiceNow) and fluency with standard MS Office applications.
• A proficient technical understanding of manufacturing-related computer systems, data, infrastructure (networking, security, wireless), and complex relational databases.
• Proven ability to network with other sites to identify, capture, and implement best practices.
Company:
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being. Founded in 1954, the company is headquartered in Greenfield, USA, with a team of 5001-10000 employees. The company is currently Late Stage.

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