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Computer System Validation Manager Jobs in Lansdowne, PA

CYNET SYSTEMS

Lab Support Engineer

West Point, PA · On-site

$41 - $46/hr

Good knowledge of Computer System Validation. * Good understanding of laboratory instruments and ... Manage end to end lab system lifecycle including implementation, validation, maintenance, and ...

Quantam

911 Systems Consultant

Philadelphia, PA · On-site

Operating system and database management * Computerized system validation * Disaster recovery and ... Skills: 911,CAD,call handling,radio,call logging,PPD,RFP,RFI,Information Technology,Computer Aided ...

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Computer System Validation Manager information

See Lansdowne, PA salary details

$44.8K

$99.4K

$151.3K

How much do computer system validation manager jobs pay per year?

As of Aug 8, 2026, the average yearly pay for computer system validation manager in Lansdowne, PA is $99,352.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,200.00 and $124,400.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Lansdowne, PA? The most popular types of Computer System Validation jobs in Lansdowne, PA are:
What job categories do people searching Computer System Validation Manager jobs in Lansdowne, PA look for? The top searched job categories for Computer System Validation Manager jobs in Lansdowne, PA are:
What cities near Lansdowne, PA are hiring for Computer System Validation Manager jobs? Cities near Lansdowne, PA with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you

System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems

Alphanumeric Systems Inc.

Collegeville, PA • On-site

$70 - $85/hr

Contractor

Medical, Dental, Vision, Retirement, PTO

Posted yesterday

New

Job description

System Level Review (SLR) & Audit Trail Review (ATR) Consultant – GxP Laboratory Systems
 
Location: Collegeville, PA (100% Onsite)
Pay: $70–85/hour W2 (depending on experience)
Benefits: Medical, Dental, Vision, 401(k), PTO, Paid Holidays, and more.
 
About the Opportunity:
Alphanumeric is seeking an experienced System Level Review (SLR) & Audit Trail Review (ATR) Consultant to support a leading global pharmaceutical organization at its Collegeville, PA campus.
This role is ideal for a Computerized System Validation (CSV) professional with hands-on experience supporting laboratory equipment and computerized systems in a regulated GxP environment. The successful candidate will perform System Level Reviews, Audit Trail Reviews, and Data Integrity assessments while ensuring laboratory systems remain compliant, inspection-ready, and aligned with FDA regulatory expectations.

Candidates with experience performing Periodic Reviews, Computerized System Reviews, or equivalent laboratory system compliance assessments are encouraged to apply.
 
What you’ll be doing:
  • Perform System Level Reviews (SLRs) for laboratory equipment and computerized systems.
  • Execute Audit Trail Reviews (ATRs) to evaluate system compliance, electronic records, and data integrity.
  • Assess laboratory systems for compliance with GxP, FDA 21 CFR Part 11, and applicable regulatory requirements.
  • Review audit trails, electronic records, user access, security controls, system configurations, and lifecycle documentation.
  • Identify data integrity risks, compliance gaps, and opportunities for remediation.
  • Author and review validation documentation, including risk assessments, validation plans, protocols, reports, periodic reviews, and change controls.
  • Support Computerized System Validation (CSV) activities throughout the system lifecycle.
  • Partner with Quality Assurance, Validation, Laboratory Operations, Engineering, and IT teams to ensure systems remain in a validated state.
  • Support internal audits, regulatory inspections, and inspection readiness initiatives.
  • Ensure validation deliverables meet established quality standards and project timelines.
 
Required Qualifications:
  • Bachelor's degree in Engineering, Computer Science, Chemistry, Biology, Life Sciences, or a related technical discipline.
  • Minimum 5 years of experience supporting GxP-regulated pharmaceutical, biotechnology, or life sciences environments.
  • Hands-on experience performing Computerized System Validation (CSV).
  • Experience conducting System Level Reviews (SLRs), Periodic Reviews, and/or Audit Trail Reviews (ATRs) for laboratory equipment or computerized systems.
  • Strong knowledge of:
    • GxP
    • FDA 21 CFR Part 11
    • Data Integrity (ALCOA+)
    • Electronic Records and Electronic Signatures
    • Change Control and Risk Assessment
  • Experience supporting laboratory computerized systems and laboratory equipment.
  • Strong technical writing, documentation, and communication skills.
 
Preferred Experience: Experience with one or more of the following systems is highly desirable:
  • Waters Empower
  • LabWare LIMS
  • LabVantage
  • Chromeleon
  • OpenLab
  • Electronic Laboratory Notebooks (ELN)
  • Veeva
  • Kneat
  • ValGenesis

Preferred Skills:
  • Computerized System Validation (CSV)
  • Data Integrity
  • Audit Trail Reviews
  • System Level Reviews
  • Laboratory Compliance
  • Risk Assessment
  • CAPA
  • Change Control
  • Root Cause Analysis
  • GAMP 5
  • Good Manufacturing Practice (GMP)
  • Laboratory Information Management Systems (LIMS)
 
Why Join Us?
This is an opportunity to support highly visible compliance initiatives within a global pharmaceutical organization. You'll work alongside cross-functional Quality, Validation, Engineering, and Laboratory teams on projects that directly impact regulatory compliance, data integrity, and inspection readiness.
 
Please Note: This is a 100% onsite position located in Collegeville, PA. Candidates must be authorized to work in the United States on a W2 basis. We are unable to accept third-party candidates or provide sponsorship now or in the future.