ZipRecruiter

Log In

1

Senior 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, ...

Pinnaql

Validation Engineer

Cincinnati, OH

The role demands deep technical expertise across the full validation lifecycle including URS development, FAT/SAT execution, and Computer System Validation (CSV) as well as hands-on experience with ...

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 ...

Forge Biologics

CSV Engineer I

Columbus, OH

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 ...

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 ...

next page

Showing results 1-20

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

Senior Computer System Validation Csv information

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

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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 Senior Computer System Validation Csv jobs in Ohio? For Senior Computer System Validation Csv jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Senior Computer System Validation Csv jobs in Ohio look for? The top searched job categories for Senior Computer System Validation Csv jobs in Ohio are:
What cities in Ohio are hiring for Senior Computer System Validation Csv jobs? Cities in Ohio with the most Senior Computer System Validation Csv job openings:
Senior 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 4 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