ZipRecruiter

Log In

1

Freelance Computer System Validation Csv Jobs in Ohio

RESILIENCE

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

RESILIENCE

CSV Engineer III

West Chester, OH

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

Resilience

CSV Engineer III

West Chester, OH · On-site

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

Forge Biologics

CSV Engineer I

Columbus, OH · On-site

The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are ... Supports computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information ...

ATS Automation

Automation Engineer

Lewis Center, OH

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Ensure commissioning and qualification activities align with ...

Inteldot

Automation Engineer

New Albany, OH · On-site

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Ensure commissioning and qualification activities align with ...

Inteldot

Automation Engineer

New Albany, OH · On-site

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Ensure commissioning and qualification activities align with ...

Inteldot

Automation Engineer

New Albany, OH

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Ensure commissioning and qualification activities align with ...

next page

Showing results 1-20

All JobsComputer System Validation Csv JobsFreelance Computer System Validation Csv JobsFreelance Computer System Validation Csv Jobs in Ohio

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 Ohio? The most popular types of Computer System Validation Csv jobs in Ohio are:
What are popular job titles related to Freelance Computer System Validation Csv jobs in Ohio? For Freelance Computer System Validation Csv jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Freelance Computer System Validation Csv jobs in Ohio look for? The top searched job categories for Freelance Computer System Validation Csv jobs in Ohio are:
What cities in Ohio are hiring for Freelance Computer System Validation Csv jobs? Cities in Ohio with the most Freelance Computer System Validation Csv job openings:
Freelance Computer System Validation Csv jobs near you

CSV Engineer III

RESILIENCE

West Chester, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 8 days ago

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
The CSV Engineer III independently plans, executes, and leads validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV). Working within the process team concept, the role applies independent technical judgment to resolve complex validation challenges, requires no instruction on routine work, and partners across engineering, quality, and operations to keep systems compliant and inspection-ready. As a technical advisor to the validation function, it coaches less-experienced team members and builds alignment on validation strategy and approach.
Job Responsibilities
Validation Execution & Technical Leadership
  • Independently plan, author, and execute validation deliverables - validation plans, protocols (IQ/OQ/PQ), and summary reports - for automation and computerized systems in accordance with GAMP 5 and applicable cGMP requirements.
  • Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance.
  • Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio.
  • Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues.
  • Communicate project priorities, risks, and progress to the process team on a continuing basis.
  • Identify and drive continuous-improvement opportunities in validation methodology, automation, and documentation practices.

Documentation & Compliance
  • Prepare and review validation documentation, ensuring activities, actions, and results are accurate, complete, and audit-ready.
  • Answer compliance and process questions from cross-functional partners and serve as a subject-matter resource during regulatory and internal audits.
  • Initiate and document appropriate corrective action when process deviations or system non-conformances occur, escalating issues beyond established procedures as needed.
  • Maintain validated state through change control, periodic review, and requalification activities.

Leadership, Coaching & Mentorship
  • Provide technical coaching and guidance to less-experienced engineers and technicians on validation methodology and automation best practices.
  • Build alignment across engineering, quality, and operations on validation requirements and acceptance criteria.
  • May oversee and direct the validation activities of others within assigned projects.

Experience & Education
Minimum Qualifications
  • Demonstrated experience in validation or process engineering.
  • Demonstrated ability to independently lead validation studies and projects from planning through execution with minimal supervision.
  • Hands-on experience with automation and computer system validation (CSV).
  • Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
  • Ability to expertly read and interpret engineering drawings, P&IDs, and system diagrams.
  • Strong analytical skills with keen attention to detail.
  • Strong written and verbal communication skills, including technical report writing.
  • Strong problem-solving abilities and sound independent judgment.
  • Ability to prioritize and manage own time and workload across concurrent projects.
  • Ability to coach peers and provide technical guidance to less-experienced team members.

Preferred Qualifications
  • Bachelor's degree in Engineering, Computer Science, or a related discipline.
  • 5+ years of experience in validation or process engineering, including hands-on automation and computer system validation.
  • Experience in a regulated or cGMP manufacturing environment.
  • Familiarity with structured software development lifecycle (SDLC), configuration management, and scripting for automated and computerized systems.
  • Hands-on experience with industrial automation platforms (e.g., Rockwell/Allen-Bradley, Siemens, or Emerson DeltaV PLC/SCADA/DCS) and data historians.
  • Familiarity with automated testing tools and validation lifecycle management (VLM) software.

Physical & Work Environment
  • Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.
  • May require gowning and adherence to cleanroom, PPE, and safety requirements.
  • Occasional lifting of up to 25 lbs and the ability to stand, walk, and access equipment on the manufacturing floor for extended periods.
  • May require work outside standard business hours to support production schedules, shutdowns, or time-sensitive validation activities.

Work Schedule
8 hours - Monday- Friday with the need of some flexibility
The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.
Sponsorship or support for work authorization, including visas, is not available for this position.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $85,000.00 - $133,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

Apply