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Computer System Validation Jobs in Allentown, PA

The Secant Group

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 ...

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 ...

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All JobsComputer System Validation JobsComputer System Validation Jobs in Allentown, PA

Computer System Validation information

See Allentown, PA salary details

$10

$53

$84

How much do computer system validation jobs pay per hour?

As of Aug 5, 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 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.

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.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
What are popular job titles related to Computer System Validation jobs in Allentown, PA? For Computer System Validation jobs in Allentown, PA, the most frequently searched job titles are:
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What cities near Allentown, PA are hiring for Computer System Validation jobs? Cities near Allentown, PA with the most Computer System Validation job openings:
Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Allentown, PA as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $111,495 per year, or $53.6 per hour.

Director, Software Validation - Hybrid - New Jersey

Slipstream IT

Hampton, NJ • On-site

$90 - $100/hr

Full-time

Posted 22 days ago

Job description

At Slipstream we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations.
Slipstream's industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth.
Job Summary
The Director, Software Validation, is responsible for establishing, maintaining, and continuously improving the company's Computer System Validation (CSV) program in alignment with applicable regulatory requirements, corporate quality policies, and industry best practices. This includes oversight of validation activities for all GxP-related computerized systems used in manufacturing, laboratory, clinical, and quality operations. Regulatory & Standards Scope This position ensures compliance with: GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. 21 CFR Part 11: Electronic Records; Electronic Signatures. EudraLex Volume 4 Annex 11: Computerized Systems. FDA Guidance on Data Integrity and Compliance With CGMP. FDA Draft Guidance on Computer Software Assurance (CSA). Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). ICH E6 (R2) Good Clinical Practice Guideline.
Key Duties & Responsibilities
  • Strategic Leadership Develop and implement a global CSV and CSA strategy.
  • Ensure alignment of CSV activities with company and regulatory requirements.
  • Lead organizational readiness for evolving regulatory expectations.
  • Operational Management Create validation deliverables including plans, risk assessments, protocols, and reports.
  • Ensure robust change control, periodic review, and system decommissioning processes.
  • Promote adoption of risk-based validation methodologies.
  • Compliance & Audit Readiness Serve as primary SME for CSV and data integrity during audits and inspections.
  • Lead remediation of any validation-related findings.
  • Maintain documentation and metrics to demonstrate compliance.
  • Cross-Functional Collaboration Partner with Quality, R&D, and Clinical Operations in execution of CSV activities.
  • Provide CSV training and mentoring to internal teams.
  • Team Development Build, develop, and lead a high-performing validation team.
  • Ensure adequate resourcing for current and future validation projects.

Education & Experience Requirements
  • Bachelor's or Master's in Computer Science, Engineering, or Life Sciences.
  • Minimum 10 years of progressive CSV experience in a GxP-regulated environment.
  • Demonstrated expertise with GAMP 5, 21 CFR Part 11, Annex 11, FDA Data Integrity guidance, and CSA.
  • Strong working knowledge of GMP, GCP, GLP, and ICH E6.
  • Experience managing cross-functional global validation programs.

Competencies & Skills
  • Deep understanding of software development lifecycles and validation approaches.
  • Exceptional leadership and team-building skills.
  • Strong analytical, problem-solving, and decision-making abilities.
  • Excellent written, verbal, and presentation skills.
  • Ability to thrive in a fast-paced, regulated environment.

Work Environment & Travel
  • Primarily remote with periodic on-site presence as required in Hampton, NJ.
  • Occasional domestic/international travel for audits, vendor assessments, or project support.

Hourly Rate
  • $90/hr.-$100/hr.

Slipstream is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream makes hiring decisions based solely on qualifications, merit, and business needs at the time.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.

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