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Computer System Validation Csv Pharmaceutical Jobs in Silver Spring, MD

Workforce Genetics

CSV Engineer

Baltimore, MD · On-site

This organization is a strategic partner to leading pharmaceutical and biotech companies ... Lead the transition from traditional, documentation-heavy Computer System Validation (CSV) to a ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ... or pharmaceutical environments preferred over medical device In-depth understanding of GAMP ...

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ... or pharmaceutical environments preferred over medical device In-depth understanding of GAMP ...

CAI

Computer Systems Validation Engineer

Baltimore, MD

$75K - $106K/yr

... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ... or pharmaceutical environments preferred over medical device In-depth understanding of GAMP ...

CAI

Computer Systems Validation Engineer

Rockville, MD

$75K - $106K/yr

... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ... or pharmaceutical environments preferred over medical device In-depth understanding of GAMP ...

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ... or pharmaceutical environments preferred over medical device In-depth understanding of GAMP ...

Catalyx

Automation SME

Gaithersburg, MD · On-site

... or pharmaceutical manufacturing environments. · Strong experience with DCS, PLC, SCADA, ISA-88 ... computerized system validation (CSV), and data integrity principles. · Experience leading ...

Deloitte

System Test and Validation Lead

Baltimore, MD · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Rosslyn, VA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Baltimore, MD · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Computer System Validation Csv Pharmaceutical information

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for computer system validation csv pharmaceutical in Silver Spring, MD is $56.15, according to ZipRecruiter salary data. Most workers in this role earn between $43.22 and $66.59 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Silver Spring, MD look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Silver Spring, MD are:

What cities near Silver Spring, MD are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities near Silver Spring, MD with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

CSV Engineer

Workforce Genetics

Baltimore, MD • On-site

Contractor

Re-posted 15 days ago

Job description

CSV Engineer (6mo. Contract-to-Hire)

Location: Baltimore, MD


Company

Join a premier global Contract Development and Manufacturing Organization (CDMO) that is rapidly expanding its state-of-the-art sterile manufacturing footprint in Baltimore. This organization is a strategic partner to leading pharmaceutical and biotech companies, specializing in the end-to-end development and commercialization of complex injectable products. With a reputation for scientific excellence and a commitment to Quality by Design, they offer a dynamic, client-facing environment where technical experts lead the transition of life-saving therapies from the lab to commercial scale.


Job Summary

The CSV Engineer will interact with QA, IT, and business area users to generate user requirements and understand system functionality and use with respect to computerized systems and data integrity. Maintain current system functionality and use to ensure cGMP regulatory compliance. Perform periodic reviews and remediation activities for validated systems.


What You'll Do

  • Possess strong knowledge of validation and related practices, including governmental regulations (e.g., 21CFR Part 11, EU Annex 11)
  • Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies
  • Act as a subject matter expert on computer validation lifecycle processes, articulating these to clients and regulatory bodies
  • Validate and qualify computerized manufacturing PLC-based and Windows-based systems in GXP environments
  • Write and review validation documentation, including Validation Plans, User Requirements, IQ/OQ/PQ Protocols, and Summary Reports
  • Perform global computerized system risk assessments and vendor evaluations
  • Drive project execution and serve as a coach/mentor to project teams to promote continuous improvement and professional growth
  • Implement Computer System Assurance (CSA) Methodologies: Lead the transition from traditional, documentation-heavy Computer System Validation (CSV) to a right-sized, risk-based CSA approach, leveraging critical thinking to focus formal testing efforts on high-risk GxP functionalities, patient safety, and data integrity.
  • Qualify Standalone GxP Software from Scratch: Manage the complete end-to-end validation lifecycle for new, bespoke, or custom-built standalone software platforms (including GAMP Class 5 applications) without relying on pre-existing vendor frameworks.
  • Perform Right-Sized Software Risk Assessments: Conduct strategic risk modeling and Failure Mode and Effects Analysis (FMEA) to distinguish high-risk GxP functions from low-risk features, establishing documented justifications to optimize the testing burden and avoid unnecessary verification.
  • Bridge Information Technology and Automation Networks: Translate complex network architectures, server security setups, and firewall configurations into GxP-compliant validation test protocols.
  • Establish Data Integrity and Digital Readiness Strategy: Drive the site's transition from legacy paper-based recording systems to electronic data acquisition and chartless recording, ensuring robust controls for audit trails, user access interfaces, and electronic records.\
  • Defend and Justify Validation Scoping: Act as the strategic owner of the CSV/CSA framework, demonstrating the confidence and technical expertise to justify and defend risk-based testing strategies to cross-functional stakeholders and regulatory bodies during audits.


What You'll Bring

  • Bachelor's degree required
  • At least 7 years of experience in computer systems validation and 21 CFR Part 11 / Annex 11 within GMP/GLP industries
  • Comprehensive knowledge of the computer validation lifecycle process
  • Fluency with SAP, PLCs, and laboratory computer systems
  • Proficiency in Microsoft Word, Outlook, and Excel


Work Environment & Role Demands

In this role, you will be expected to organize and coordinate complex tasks, solving issues independently using sound judgment. You should be comfortable working in a fast-paced environment with frequent interruptions. The position requires strong visual acuity and eye/hand coordination for keyboard use and traversing laboratory areas. You will primarily work on-site with minimal travel, occasionally working around extreme temperatures or noise above conversation levels. Regular and predictable attendance is essential to support our laboratory operations.