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Biotech Csv Jobs in Raleigh, NC (NOW HIRING)

Syner-G

Sr. Validation Engineer

Raleigh, NC · On-site

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Zifo

Principal CQV Consultant

Cary, NC · On-site

Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients. * Identify new ... Provide SME oversight for ongoing CQV engagements (IQ/OQ/PQ, CSV, lab instrument qualification ...

Zifo

Principal CQV Consultant

Cary, NC · On-site

Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients. * Identify new ... Provide SME oversight for ongoing CQV engagements (IQ/OQ/PQ, CSV, lab instrument qualification ...

Syner-G

Sr. Validation Engineer

Raleigh, NC · On-site

Technical Experience * 7-11 years of experience in the biotech, pharmaceutical, or medical device ... Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and ...

Experis

SAP Project Manager

Durham, NC · On-site

Experience working in regulated industries such as medical device, healthcare, pharmaceutical, or biotechnology. * Knowledge of Computer System Validation (CSV) requirements. * Experience using ...

PM Group

Site MES IT Coordinator

Zebulon, NC · On-site

We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors ... Familiarity with regulated manufacturing environments and computerized system validation (CSV ...

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Biotech Csv information

What are common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What is a Biotech CSV professional?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are the key skills and qualifications needed to thrive as a Biotech CSV specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.
What are popular job titles related to Biotech Csv jobs in Raleigh, NC? For Biotech Csv jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Biotech Csv jobs in Raleigh, NC look for? The top searched job categories for Biotech Csv jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Biotech Csv jobs? Cities near Raleigh, NC with the most Biotech Csv job openings:
Biotech Csv jobs near you
Infographic showing various Biotech Csv job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 4% Part Time, 1% Temporary, and 8% Contract. Highlights an 81% Physical, 5% Hybrid, and 14% Remote job distribution.

Quality Data Steward (LIMS/eQMS) - Pharmaceutical

Kelly Services

Raleigh, NC

$76K - $110K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 20 hours ago

Posted today

Job description


Quality Data Steward (LIMS/eQMS) – Pharmaceutical Manufacturing
Location: Raleigh, NC
Schedule: Fully Onsite | Monday–Friday | Normal Business Hours
Salary: $76,000–$110,000
Position Summary
The Data Steward is responsible for ensuring the accuracy, integrity, security, and compliance of quality-related electronic data across regulated systems including LIMS, SAP, and eQMS. This role supports data governance by maintaining data standards, monitoring data quality, and ensuring compliance with FDA, cGMP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles. Working cross-functionally with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain, the Data Steward helps drive data integrity, regulatory compliance, and informed business decisions.
Key Responsibilities
  • Administer and maintain LIMS to ensure data accuracy, integrity, security, and regulatory compliance.
  • Serve as the subject matter expert (SME) for LIMS by providing system support, troubleshooting, and issue resolution.
  • Support SAP Quality Management functions, including master data, system enhancements, upgrades, and troubleshooting.
  • Monitor data quality, investigate data anomalies, and implement corrective actions.
  • Support implementation, validation, and maintenance of electronic quality systems and system upgrades.
  • Author, review, and maintain SOPs, specifications, protocols, reports, and system documentation.
  • Ensure compliance with cGMP, FDA regulations, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, and internal quality systems.
  • Support Computer System Validation (CSV) activities, including change controls, risk assessments, testing, and validation documentation.
  • Assist with internal audits, regulatory inspections, data integrity assessments, CAPAs, and remediation activities.
  • Generate, analyze, and report laboratory and quality data to identify trends and support investigations.
  • Support Annual Product Reviews (APRs), quality metrics, and management reporting.
  • Train users on LIMS, SAP, electronic systems, and data management processes.
  • Collaborate with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain to resolve system and data-related issues.
  • Perform additional duties and special projects as assigned.
Qualifications
Required
  • Bachelor's degree in a scientific, technical, or related field.
  • Minimum of five (5) years of experience in the pharmaceutical, biotechnology, medical device, or other regulated industry.
  • Experience with LIMS, SAP Quality Management, eQMS, or other electronic quality systems.
  • Strong knowledge of cGMP, FDA regulations, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
  • Experience supporting data governance, electronic data management, and quality systems.
  • Strong analytical, troubleshooting, organizational, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
Preferred
  • Experience with Computer System Validation (CSV) and change control.
  • Experience supporting audits, regulatory inspections, CAPAs, investigations, and quality risk assessments.
  • Familiarity with laboratory operations, analytical testing, and Quality Control environments.
  • Experience with quality metrics, data analysis, and reporting.
  • Lean Six Sigma, ASQ, or other quality certifications are a plus.
Work Environment
  • Fully onsite position based in Raleigh, NC.
  • Standard Monday–Friday business hours.
  • Office-based role with regular interaction in laboratory and manufacturing environments.
  • Frequent computer-based work involving electronic quality systems and data management.
  • Must be able to wear appropriate PPE when entering laboratory or manufacturing areas.
  • Occasional schedule flexibility may be required to support audits, system implementations, validation activities, or business needs.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.