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Computer System Validation Jobs in Allentown, PA

Solesis

Validation Specialist II

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 ...

Secant

Validation Specialist II

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 ...

System One

QA Validation Engineer

Bethlehem, PA · On-site

Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems * Reviews and approves validation project documentation

Thermo Fisher Scientific

Technical Writer

Allentown, PA · On-site

What You'll Do: • Serve as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g. review computer system validation data, lab investigations, root cause ...

CAI

Validation Engineer

Allentown, PA

$72K - $80K/yr

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential ...

CAI

Validation Engineer

Allentown, PA

$72K - $80K/yr

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential ...

CAI

Validation Engineer

Fogelsville, PA

$72K - $80K/yr

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential ...

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Computer System Validation information

See Allentown, PA salary details

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$53

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How much do computer system validation jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for computer system validation in Allentown, PA is $53.60, according to ZipRecruiter salary data. Most workers in this role earn between $41.30 and $63.56 per hour, depending on experience, location, and employer.

What is a computer system validation?

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.

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

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.

What are some typical challenges faced in computer system validation roles?

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.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for professionals with skills in validation protocols, regulatory requirements, and tools like GxP and 21 CFR Part 11. The field provides steady employment, career growth, and the chance to work on critical quality assurance processes.

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For Computer System Validation jobs in Allentown, PA, the most frequently searched job titles are:

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The top searched job categories for Computer System Validation jobs in Allentown, PA are:

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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Allentown, PA as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 16% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $111,495 per year, or $53.6 per hour.

Validation Specialist II

The Secant Group, LLC

Telford, PA

Full-time

Re-posted yesterday

Job description

What we are looking for:

The Validation Specialist II coordinates and implements various activities for compliant and effective support of the Secant Group Validation functions conforming to ISO 13485, internal, and customer requirements. Responsible for performing multiple validation disciplines including Software Validation (SV), Equipment Qualification (IOQ) and minor Software Programming. Also responsible for maintenance of the validated state of qualified utilities, equipment and software as required. Responsible for Performing Periodic Reviews of equipment and software per program requirements. The Validation Specialist II helps manage the Software Validation Programs for Solesis Sister Companies Charter Medical LLC and Polyzen LLC to ensure compliance with FDA and current industry software requirements.

What you will do:

  • Support Secant Group Customer and ISO 13485 audits and help defend the Software Validation Program during audits.
  • Support Charter Medical and Polyzen Customer Audits, ISO 13485 Audits and FDA Inspections to help defend the Software Validation Program.
  • Responsible for managing consultants on large projects with oversight from upper management.
  • Responsible for Qualifying (IOQ) new direct impact production and support equipment and systems. This involves writing, reviewing, approving and executing validation protocols.
  • Responsible for validating all new direct impact software that is utilized within the Secant Group, Charter Medical or Polyzen Quality Management System. This involves writing, reviewing, approving and executing software validation protocols, User Requirement Specifications (URSs) and Risk Assessments (FMEAs) as applicable.
  • Responsible for maintaining the validated state of qualified systems (software, utilities, facility, equipment) as required to support any system changes or negative data trending issues by completing IOQ and/or PQ protocol addendums or verification memos as required by the change control systems.
  • Provide Software Programming support to IT and Quality Groups of the Solesis Companies as required to maintain production requirements.
  • Responsible for supporting Sister Company SanaVita Medical LLC as required concerning equipment qualification and software validation.
  • Drafts documentation needed to support company operations and compliance including SOPs, WIs, Specifications, Test Methods, Change Controls, and CAPA/Nonconformance Reporting.
  • Provides support for additional quality systems and functional areas as needed and/or assigned including, but not limited, to Preventive/Unscheduled Maintenance and Calibration, Validation, Training, Research & Development, and Product/Process Development, Manufacturing and Quality Engineering groups.
  • Assist Validation Manager provide oversight of the Charter Medical and Polyzen Software Validation programs and performs software validations as required.
  • Assess new Charter Medical and Polyzen QMS Software for applications for FDA 21CFR Part 11 requirements.
  • Helps maintain Software and Equipment Validation Master Plans for tracking validation activities and validated system periodic reviews or software version upgrades.
  • Stays current with technical and regulatory requirements and applies new knowledge to the position.
  • Performs additional job-related responsibilities as assigned.

Who you are:

  • Minimum bachelor’s degree in science or engineering. BS in a software or computer related degree preferred but not required with adequate software experience.
  • High level of competence interacting with Computers/Software - Using computers and computer systems (including hardware and software) to configure, program, set up functions, enter data, or process information.
  • 2-5 years’ experience with writing Software User Requirements Specifications, performing Risk Assessments and writing/executing Software Validation protocols.
  • 1-3 years Equipment Qualification (IOQ) experience in a regulated environment preferred but not required.
  • Knowledge of regulated environment and Quality Management System (QMS) (e.g., FDA GMP Part 820 and/or ISO 13485) preferred.
  • Knowledge of web-based programs, software and database applications and technologies required.
  • Understanding of FDA 21CFR Part 11 for Software Validation preferred
  • General understanding of ISPE GAMP5 Software Validation Guidance preferred.
  • Ability to write Detailed Design Documents and Functional Requirements Specifications preferred.
  • Experience working in a cleanroom environment is preferred.