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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 validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

Enhance CSV validation programs * Analyze validation data, identify gaps, and support investigations and corrective actions * Represent CSV during audits and regulatory inspections SPECIAL WORK ...

Bristol-Myers Squibb Company

Lead Engineer, CSV

Summit, NJ · On-site

$108K - $143K/yr

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, implementation and support of manufacturing and laboratory equipment and computerized ...

Validation & Engineering Group, Inc

PR

$59K - $60K/yr

Associate CSV - Periodic Review Scientist Position Summary The Associate CSV Periodic Review Scientist supports the execution of periodic reviews for GxP computer systems to ensure compliance with ...

Yochana IT Solutions

CSV Engineer

Raritan, NJ · Remote

$73K - $95K/yr

Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience. Proven ...

New

Bristol Myers Squibb

Lead Engineer, CSV

Summit, NJ

$108K - $143K/yr

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, implementation and support of manufacturing and laboratory equipment and computerized ...

Noblesoft Technologies

CSV Engineer

Raritan, NJ · On-site

CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications / SAP / MES • Experience in validating ERP/SAP/ MES Manufacturing applications • 3+ years ...

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How much do csv jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for csv in the United States is $52.48, according to ZipRecruiter salary data. Most workers in this role earn between $40.87 and $64.42 per hour, depending on experience, location, and employer.

What job makes $10,000 a month without a degree?

High-paying jobs that can reach $10,000 a month without a degree often include roles such as sales managers, real estate brokers, or skilled trades like electricians and plumbers, especially with experience and certifications. Success in these fields typically depends on skills, performance, and networking rather than formal education, and they may require licensing or specialized training.

What is a CVS position?

A CVS position refers to a job at CVS Health, a retail pharmacy chain, or a role within the company. Common positions include pharmacy technician, cashier, or store associate, often requiring customer service skills and familiarity with retail environments.

What is the difference between Csv vs Data Analyst?

AspectCsvData Analyst
Required CredentialsBasic knowledge of data formats, often no formal degree requiredBachelor's degree in statistics, data science, or related field
Work EnvironmentData entry, data cleaning, often in office or remote settingsAnalyzing data, creating reports, collaborating with teams
Industry UsageUsed across industries for data managementApplied in finance, marketing, healthcare, and more
Search & Comparison IntentUnderstanding data formats and toolsAnalyzing data to inform business decisions

While Csv refers to a data format used for storing and exchanging data, a Data Analyst is a professional who interprets and analyzes data to help organizations make informed decisions. Csv is a tool or format that Data Analysts often work with, but they are distinct concepts: Csv is a file type, whereas Data Analyst is a job role.

What are the key skills and qualifications needed to thrive as a Civil Engineer, and why are they important?

To thrive as a Civil Engineer, you need a solid background in mathematics, physics, engineering principles, and typically a bachelor's degree in civil engineering or a related field. Familiarity with design software such as AutoCAD, Civil 3D, and knowledge of building codes or licensure (e.g., Professional Engineer certification) are usually required. Strong problem-solving, project management, and communication skills help you work effectively within teams and with clients. These competencies ensure the safe, efficient, and successful completion of infrastructure projects.

What are some common challenges faced by Customer Service Representatives (CSRs) and how can they be managed effectively?

Customer Service Representatives often encounter challenges such as handling difficult customers, managing high call volumes, and adapting to changing company policies. Effective communication, patience, and strong problem-solving skills are key to overcoming these obstacles. Many organizations provide ongoing training, access to knowledge bases, and supportive team environments to help CSRs succeed. Building resilience and seeking feedback from supervisors and peers can also aid in managing workplace stress and improving performance.

What is a CSV job?

A CSV job typically involves working with comma-separated values (CSV) files, which are used to store and organize data in a tabular format. Roles may include data entry, data analysis, or database management, often requiring skills in spreadsheet software, scripting, or data processing tools.

How to become a CSV?

To become a CSV (comma-separated values) professional, focus on developing skills in data management, spreadsheet software, and basic programming languages like Python or SQL. Gaining experience with data analysis tools and obtaining relevant certifications can also improve job prospects in this field.

What are CSV files and what do they do?

CSV stands for 'Comma-Separated Values.' It is a widely-used file format for storing tabular data, such as a spreadsheet or a database. Each line in a CSV file represents a row of data, and each value within the row is separated by a comma. CSV files are simple to create and use, making them a popular choice for data exchange between different applications and platforms. They can be opened with spreadsheet software like Microsoft Excel or text editors.
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CSV Engineer I

CSV Engineer I

Forge Biologics

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 21 days ago

Job description

Forge Your Future with Us:
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.
At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.
If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.
About The Role:
The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys BMS. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.
Responsibilities:
  • Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
  • Supports computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc), ERP System (NetSuite).
  • Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
  • Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
  • Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining validated state.

Qualifications:
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivelant experience).
  • 2+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
  • Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
  • Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (BMS) like Metasys.
  • Strong technical writing skills and ability to execute protocols with minimal supervision.
  • Ability to work onsite (in Columbus, Ohio) 3-4 days/week on average.

Preferred Skills:
  • Experience with Veeva Vault platform (QMS or QualityDocs) and BMRAM configuration or validation.
  • Hands-on validation of laboratory instruments (e.g., HPLC, UV-Vis,)including software like Empower or Chromeleon.
  • Familiarity with Metasys BMS or similar environmental monitoring systems in a GxP facility.
  • Experience with electronic execution systems such as Veeva Vault Manager or similar.
  • Experience supporting regulatory inspections (FDA, EMA) and responding to CSV-related observations.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We've Got You Covered:
At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one
  • Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.

Time to recharge
  • A competitive paid time off plan - because rest fuels innovation.
  • 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact
  • Annual bonus opportunities for all full-time team members.
  • 401(k) with company match to help you plan for the future.
  • Special employee discounts, including childcare and dependent care savings.

Your wellness, supported
  • Onsite fitness facility at The Hearth.
  • Mental health counseling and financial planning services through our Employee Assistance Program.
  • Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday
  • A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.

Grow with us
  • Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Apply