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Medical Device Computer System Validation Jobs (NOW HIRING)

Lonza

Computer Systems Validation Engineer

Portsmouth, NH · On-site

$80 - $100/hr

Minimum of 5 years of experience working with automation and/or computerized system validations ... Biotech/Pharma/Medical Device/Medical or biologics industry experience required. * Ability to work ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$45 - $50/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$150 - $200/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

Yochana IT Solutions

Validation Lead-Remote

Raritan, NJ · On-site

Raritan, NJ(Hybrid) Duration: 6+ Months Job Details: 5+ years of Computer System Validation (CSV ... Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and ...

Jubilant Pharma, LLC

$100 - $125/hr

Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because ... Responsible for the computerized system validation and data integrity at the JHS-Spokane site. The ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site

Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA ...

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Job Title: Medical Device Assembler Location: Madison, WI (Onsite) Pay Rate: $23-24/hr on W2 ... Self-directed Teamwork Good communication skills Proficient with computer systems Critical thinking ...

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Medical Device Computer System Validation information

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How much do medical device computer system validation jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for medical device computer system validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is medical device computer system validation?

Medical Device Computer System Validation (CSV) is the process of ensuring that software and computer systems used in the manufacturing, testing, or management of medical devices meet regulatory requirements and function as intended. This involves documenting that all systems are installed correctly, operate reliably, and consistently produce accurate data. CSV is critical for patient safety, product quality, and regulatory compliance, particularly with standards like FDA 21 CFR Part 11 and ISO 13485. The validation process typically includes planning, risk assessment, testing, and ongoing monitoring throughout the system's lifecycle.

What are the key skills and qualifications needed to thrive as a medical device computer system validation specialist?

To thrive as a Medical Device Computer System Validation specialist, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and computer science or engineering principles, often supported by a relevant degree or certification. Familiarity with validation protocols, quality management systems (QMS), and software tools like ALM or TrackWise is essential. Strong attention to detail, analytical thinking, and effective communication skills help ensure validation activities meet strict industry standards. These skills are vital for safeguarding patient safety, ensuring product quality, and maintaining regulatory compliance in the medical device industry.

What are some common challenges faced by professionals in medical device computer system validation and how can they be addressed?

Professionals in Medical Device Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring thorough documentation, and coordinating with cross-functional teams like IT, quality assurance, and engineering. Staying updated with current FDA guidelines and international standards (such as ISO 13485) is crucial. Clear communication and collaboration with team members can streamline validation activities and help address gaps early. Utilizing robust project management tools and maintaining organized, audit-ready documentation can also significantly reduce stress and improve efficiency.

What is the difference between Medical Device Computer System Validation vs Quality Assurance Specialist?

AspectMedical Device Computer System ValidationQuality Assurance Specialist
Primary FocusEnsuring computer systems meet regulatory and functional requirements for medical devicesMaintaining product quality through process audits and compliance
CertificationsGxP, 21 CFR Part 11, Validation certificationsISO 9001, Six Sigma, QA certifications
Work EnvironmentRegulated labs, validation teams, manufacturing settingsQuality departments, manufacturing plants, audits
Industry UsageMedical device manufacturing, regulatory submissionsProduct quality, process improvement, compliance

Medical Device Computer System Validation specialists focus on verifying that computer systems used in medical device manufacturing comply with regulatory standards. Quality Assurance Specialists oversee overall product quality and process compliance. While both roles ensure regulatory adherence, validation is specifically about system verification, whereas QA covers broader quality management.

QC Informatics Specialist (Computer System Validation)

Coventry, RI • On-site

Pharmaron
Chemical Manufacturing • 10K+ employees
Learn more about Pharmaronexternal

$80K - $120K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Job description

Position: Computer System Validation/QC Informatics Specialist

Salary Range: $80,000 - $120,000/yr.

Location: Coventry, RI (On-site)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

To support process chemistry and manufacturing activities through management of laboratory data software platforms and workflows. This role is positioned within the Quality Control & Analytical department to develop and support their requirements and workflows and to act as liaison with IT and QA to minimize downtime, improve effectiveness and maintain compliance related to laboratory data generation, storage, and use.

Key Responsibilities

  • With the support of the reporting manager in the Quality Control & Analytical department, lead laboratory improvement efforts related to laboratory information handling such as custom report generation, ELN, LIMS system configuration, data storage/organization, and pharmaceutical data workflows.
  • Liaising with appropriate technical and IT stakeholders to manage GxP software upgrades, installations, and roll outs to ensure business continuity and effectiveness are maintained and improved.
  • Author, review, and perform GxP qualification activities related to QCA as part of the Computer System Validation (CSV) life cycle e.g. GxP Risk & Impact Assessments, URS/FS, Qualification Plan, IQ, OQ, PQ, Requirement Tractability Matrix, Quality Summary Report, periodic reviews and decommissioning activities.
  • Demonstrating expertise in site-wide, complex software platforms e.g. NuGensis LMS, SDMS, ELN, Empower 3 etc. as well as various other standalone laboratory system software used within QCA and Process Chemistry.
  • Support System Owners within business functions with training end users in the use of the system.
  • Liaise between end users and IT to clearly communicate business priorities and ensure that appropriate resources are used to maintain ongoing business operations.
  • Build effective business relationships with all stakeholders.
  • Support departmental or site audits as directed by manager/supervisor as necessary

What We're Looking For

  • MSc or BSc in Chemistry, or Computer Science, or related fields with minimum of 5 years of GxP experience.
  • If qualified in chemistry or a related field, then strong experience in an IT supporting role must be demonstrated including a basic understanding of data structures, programming, and/or information systems.

If qualified in computer science or a related field, then strong experience in an analytical laboratory supporting role must be demonstrated including a basic understanding of common chemistry terminology, application, and laboratory workflows.

  • Direct experience with laboratory informatics (LIMS) systems.
  • Understanding of common GxP topics including QMS, ALCOA+, 21 CFR Part 11, and Data Integrity principles.
  • Evidence of ability to effectively work cross-functionally between IT and scientific teams
  • Working knowledge of applicable FDA, EMA, GAMP, and/or ICH guidance as it relates to data integrity.
  • Evidence of ability to manage stepwise implementation and qualification projects.
  • Good knowledge on pharmaceutical compliance and latest industry requirements.
  • Functional experience in the technical administration of complex laboratory informatics software platforms such as NuGenesis LMS, SDMS and ELN.
  • Effective written and oral communication skills, including the ability to effectively present complex information to colleagues.
  • Effective in managing multiple competing activities and delivering to timelines.
  • Ability to work professionally in a cross-functional environment and clearly reinterpret/translate concepts across IT and Laboratory staff.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

  • Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
  • 401(k) Retirement Plan with generous employer matching
  • Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
  • Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
  • 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
  • Employee Assistance Program (EAP), mental health resources, and wellness programs
  • Family-friendly benefits, including fertility support and maternity resources
  • Professional development and career growth opportunities within a leading global CRO/CDMO

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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