Global UDI
West Chester, PA · On-site
Familiarity with computer system validation (CSV) and digital quality controls. * Experience supporting regulatory inspections or audits related to data integrity or digital systems. * Knowledge of ...
New
West Chester, PA · On-site
Familiarity with computer system validation (CSV) and digital quality controls. * Experience supporting regulatory inspections or audits related to data integrity or digital systems. * Knowledge of ...
New
West Chester, PA · On-site
Familiarity with computer system validation (CSV) and digital quality controls. * Experience supporting regulatory inspections or audits related to data integrity or digital systems. * Knowledge of ...
New
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Exton, PA · On-site
$75K - $85K/yr
What You'll DoAre you an experienced Computerized Systems Validation (CSV) professional with a ... What We're Looking ForBachelor's degree in Computer Science, Engineering, Life Sciences, or a ...
Quick apply
Exton, PA · On-site
$75K - $85K/yr
What You'll DoAre you an experienced Computerized Systems Validation (CSV) professional with a ... What We're Looking ForBachelor's degree in Computer Science, Engineering, Life Sciences, or a ...
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Exton, PA · On-site
$75K - $85K/yr
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...
Montgomeryville, PA · On-site
Work on a variety of programmable logic controller systems and a variety of Distributed Controls Systems (DCS). Configure, validate, and test the HumanMachine Interface (HMI) systems with the control ...
Montgomeryville, PA · On-site
Work on a variety of programmable logic controller systems and a variety of Distributed Controls Systems (DCS). Configure, validate, and test the HumanMachine Interface (HMI) systems with the control ...
Philadelphia, PA · On-site
$35/hr
Perform system audits, data validations, and data integrity reviews. * Support Workday releases, upgrades, enhancements, and ongoing platform improvements. * Coordinate and execute system testing ...
Philadelphia, PA · On-site
$35/hr
Perform system audits, data validations, and data integrity reviews. * Support Workday releases, upgrades, enhancements, and ongoing platform improvements. * Coordinate and execute system testing ...
Horsham, PA · On-site +1
Catalyx Services, LLC seeks a Validation Engineer reporting to office in Montgomeryville, PA to prepare various control systems validation documents, including user requirement specifications ...
Horsham, PA · On-site +1
Catalyx Services, LLC seeks a Validation Engineer reporting to office in Montgomeryville, PA to prepare various control systems validation documents, including user requirement specifications ...
Catalyx Services, LLC seeks a Validation Engineer reporting to office in Montgomeryville, PA to prepare various control systems validation documents, including user requirement specifications ...
Catalyx Services, LLC seeks a Validation Engineer reporting to office in Montgomeryville, PA to prepare various control systems validation documents, including user requirement specifications ...
Own data integrity and computer system validation (CSV) for GxP-relevant systems, including 21 CFR Part 11 (electronic records and signatures), ALCOA+ data-integrity principles, and audit-trail ...
Own data integrity and computer system validation (CSV) for GxP-relevant systems, including 21 CFR Part 11 (electronic records and signatures), ALCOA+ data-integrity principles, and audit-trail ...
Philadelphia, PA · On-site
$42K - $48K/yr
Ability to operate a wide variety of system components to include hardware, software, and mass ... Help Desk Tier II & III - may be obtained on day 1 * Must have the following: valid state driver ...
Philadelphia, PA · On-site
$42K - $48K/yr
Ability to operate a wide variety of system components to include hardware, software, and mass ... Help Desk Tier II & III - may be obtained on day 1 * Must have the following: valid state driver ...
Exton, PA · On-site
$75K - $95K/yr
... computer system validation (CSV), SDLC methodologies, and risk-based system assessmentsStrong analytical, organizational, and communication skills with the ability to work effectively across ...
Quick apply
Exton, PA · On-site
$75K - $95K/yr
... computer system validation (CSV), SDLC methodologies, and risk-based system assessmentsStrong analytical, organizational, and communication skills with the ability to work effectively across ...
West Point, PA · On-site
$41 - $46/hr
Good knowledge of Computer System Validation. * Good understanding of laboratory instruments and analytical techniques. * Familiarity with lab software systems. * Strong problem-solving and ...
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West Point, PA · On-site
$41 - $46/hr
Good knowledge of Computer System Validation. * Good understanding of laboratory instruments and analytical techniques. * Familiarity with lab software systems. * Strong problem-solving and ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
Telford, PA · On-site
The Validation Specialist II coordinates and implements various activities for compliant and ... High level of competence interacting with Computers/Software - Using computers and computer systems ...
Telford, PA · On-site
The Validation Specialist II coordinates and implements various activities for compliant and ... High level of competence interacting with Computers/Software - Using computers and computer systems ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Exton, PA · On-site
$75K - $95K/yr
Familiarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessments * Strong analytical, organizational, and communication skills with the ability to work ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Execute approved IOQ protocols for packaging equipment and associated systems * Perform field ...
$10.11 - $16.67
2% of jobs
$16.67 - $23.22
9% of jobs
$23.22 - $29.78
1% of jobs
$29.78 - $36.34
4% of jobs
$40.32 is the 25th percentile. Wages below this are outliers.
$36.34 - $42.90
15% of jobs
$42.90 - $49.46
9% of jobs
The median wage is $54.92 / hr.
$49.46 - $56.02
13% of jobs
$61.24 is the 75th percentile. Wages above this are outliers.
$56.02 - $62.57
29% of jobs
$62.57 - $69.13
12% of jobs
$69.13 - $75.69
2% of jobs
$75.69 - $82.25
5% of jobs
$10
$51
$82
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
The most popular types of Computer System Validation jobs in Philadelphia, PA are:
For Computer System Validation jobs in Philadelphia, PA, the most frequently searched job titles are:
The top searched job categories for Computer System Validation jobs in Philadelphia, PA are:
Cities near Philadelphia, PA with the most Computer System Validation job openings:

West Chester, PA • On-site
Full-time
Retirement, PTO
Posted 3 days ago
New
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Project/Program Management GroupJob Sub Function:
Project/Program ManagementJob Category:
ProfessionalAll Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of AmericaJob Description:
DePuy Synthes is recruiting for a(n) Global UDIlocatedinRaynham, Massachusetts
The Global UDI role plays a critical part inensuringDePuy Synthes' global compliance with Unique Device Identification (UDI) regulatory requirements through robust quality oversight of enabling technologies, systems, and processes. This position partnerscrossfunctionallywith Regulatory Affairs, IT, Supply Chain, and Manufacturing to ensure UDI data accuracy, system validation, and sustained compliance across global markets. The role offers high visibility, global impact, and the opportunity to influenceenterpriselevelquality and digital transformation initiatives supporting patient safety and regulatory excellence.
Key Responsibilities
Provideoversightfor global UDI technology platforms, data flows, and supporting systems to ensure regulatory compliance and data integrity.
Support development, implementation, and maintenance ofUDIrelatedquality processes, procedures, and controls across the product lifecycle.
Partner with IT and business stakeholders to ensure UDI systems arevalidated, maintained, and compliant with applicable quality system regulations.
Review and approveUDIrelateddocumentation, including system validation deliverables, change controls, risk assessments, and procedural updates.
Monitor and assess UDI data accuracy, completeness, and timeliness across internal systems and external regulatory databases.
Support internal and external audits, inspections, and health authority interactions related to UDI and supporting technologies.
Identifyquality risks, trends, and improvement opportunities related to UDI processes and digital solutions; drive corrective and preventive actions.
Provide quality guidance and training tocrossfunctionalpartners on UDI requirements, quality standards, and system controls.
Qualifications
Education
Required:Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, ora relateddiscipline.
Preferred: Advanced degree in Quality, Regulatory, ora technicalfield.
Experience and Skills
Required:
Typically4-8 years of experience in Quality Assurance, Quality Systems, orRegulatoryadjacentroles within medical devices, pharmaceuticals, or regulated industries.
Experience supporting validated systems and technology platforms in a regulated environment.
Working knowledge of global UDI regulations (e.g., FDA, EU MDR) and quality system requirements.
Experience with change control, risk management, and documentation review within a quality framework.
Demonstrated ability to analyze quality data,identifytrends, and drive continuous improvement.
Preferred:
Experience with UDI databases, labeling systems, or enterprise data management platforms.
Familiarity with computer system validation (CSV) and digital quality controls.
Experience supporting regulatory inspections or audits related to data integrity or digital systems.
Knowledge of Lean, Six Sigma, or continuous improvement methodologies.
Experience working in a global or matrixed organization.
Strong collaboration skills with the ability to work effectively across global,crossfunctionalteams.
Other:
Language: Englishproficiencyrequired.
Travel: Up to ~10-15%, domestic and occasional international.
Certifications: ASQ certifications (e.g., CQA, CQE) or similar quality certifications preferred.
For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visitwww.careers.jnj.com
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Required Skills:
Preferred Skills:
Agility Jumps, Analytics Insights, Business Alignment, Business Behavior, Collaboration Tools, Communication, Cost-Benefit Analysis (CBA), Data Analysis, Monitoring, Evaluation, and Learning (MEL), Problem Solving, Process Oriented, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Support, Statement of Work (SOW), Time ManagementThe anticipated base pay range for this position is :
110,500.00 USD AnnualAdditional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits