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Freelance Computer System Validation Csv Jobs in Indiana

Elanco

Engineer, IT Manufacturing QC Labs

Clinton, IN · On-site

$68K - $88K/yr

A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles. * Process Control Understanding: Familiarity with industrial automation ...

Roche

Application & Integration Expert

Indianapolis, IN

$85K - $157K/yr

Lead Computer System Validation (CSV) activities and provide on-site commissioning support * Develop and enforce SCADA development standards, naming conventions, and best practices * Mentor and ...

Roche

Quality & Compliance Expert

Indianapolis, IN · On-site

$82K - $117K/yr

Participate in the development of new standards and the revision of existing standards related to Computer Systems Validation (CSV). * Assemble global feedback on proposed or existing standards and ...

Reckitt

Sr. Automation Engineer

Evansville, IN · On-site

$95K - $143K/yr

Lead testing and validation efforts such as FAT, SAT, commissioning, and Computerized System Validation (CSV) * Collaborate with engineering teams, contractors, and vendors to enforce standards ...

INCOG

Senior Validation Engineer

Fishers, IN

Computer System Validation experiencepreferred * Cleaning Validation experience preferred * VHP & Steam Sterilization experience preferred Additional info about INCOG BioPharma Services: At INCOG ...

CYNET SYSTEMS

Senior Test Engineer

Indianapolis, IN · On-site

$45/hr

Support audit readiness, compliance validation (CSV), and documentation activities (GxP / 21 CFR ... Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading ...

Evonik

Engineering Technician

Lafayette, IN

Maintain computer system validation to current standards. * Lead the automation design, development, and implementation requirements associated with capital projects and process changes. * Support ...

Evonik Industries

Engineering Technician

Lafayette, IN · On-site

Maintain computer system validation to current standards. * Lead the automation design, development, and implementation requirements associated with capital projects and process changes. * Support ...

Catalyx

Automation Project Lead

Indianapolis, IN

$90K - $119K/yr

... and computer system validation principles Strong knowledge of GMP's, regulatory requirements and computer system validation principles Excellent written and verbal communication skills for both ...

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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.
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Freelance Computer System Validation Csv jobs near you
Process Automation Engineer

Process Automation Engineer

Elanco Animal Health Incorporated

Clinton, IN • On-site

Full-time

Retirement, PTO

Re-posted 18 days ago

Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

44th of 74 rated pharmaceutical

Job description

At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Process Automation Engineer
As a Process Automation Engineer, you will support the Clinton Manufacturing site by delivering and optimizing automation and control systems that drive safe, reliable, and efficient operations. In this role, you'll partner with cross-functional teams to plan, implement, and support Operational Technology (OT) solutions that improve quality, throughput, and cost while advancing the site's automation strategy and lifecycle management.
Your Responsibilities:
  • Provide troubleshooting, maintenance, change management, and ongoing support for control systems (PLCs, HMIs, DeltaV, vision, etc.) to ensure reliable operations
  • Lead and support small to medium automation projects, including planning, coordination of internal/contract resources, scheduling, and issue resolution
  • Identify and implement process improvements and optimized control strategies to enhance safety, quality, and productivity
  • Partner with Operations, Engineering, and Quality to ensure validated, compliant automation solutions that meet business requirements
  • Train, mentor, and influence site teams to increase effective use of automation systems, data, and tools

What You Need to Succeed (minimum qualifications):
  • Education: Bachelor's Degree in Engineering (Controls, Automation, Computer/Control Systems, or related field)
  • Required Experience: Experience with industrial control system programming and support (PLCs, HMIs, DCS such as DeltaV) in a manufacturing environment
  • Top 2 skills: Strong project management and prioritization skills combined with excellent communication and cross-functional collaboration

What will give you a competitive edge (preferred qualifications):
  • Experience in a regulated manufacturing environment (pharma, biotech, food, or similar)
  • Knowledge of computer system validation (CSV) and change control practices
  • Experience supporting Operational Technology (OT) lifecycle strategy and system upgrades
  • Demonstrated ability to deliver automation-driven process improvements and business value
  • Experience coordinating contractors and cross-functional project teams

Additional Information:
  • Location: Clinton, IN - On-site manufacturing environment (24/7 support as business needs require)

Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Up to 6% 401K matching

#LI-BP1
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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