Lab System Validation Engineer (GAMP5 / CSV) | Computerized System Validation (CSV) Specialist - Pharmaceuticals

Job Title: Lab System Validation Engineer (GAMP5 / CSV) | Computerized System Validation (CSV) Specialist – Pharmaceuticals

Location: West Point, PA 19486

Work Arrangement: Onsite

Employment Type: Contract

Duration: 6+ months

Pay Range: $38.71/hr. to $40.00/hr. on W2 | $46.43/hr. to $52.00/hr. on C2C

Domain: Life Sciences | Pharmaceuticals & Bio-Tech

Application Deadline: June 16, 2026

SKILLS REQUIRED

Primary (Must-Have):

• Extensive experience in Computerized System Validation (CSV) within the pharmaceutical domain.

• Deep understanding of regulatory standards including US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Proven track record of executing CSV validation in Quality Control (QC) or R&D Laboratory Systems.

• Hands-on experience developing core validation artifacts: URS, MVP, VP, RTM, TP, IQ, OQ, PQ, and VSR/TSR.

• Strong familiarity with the V-Model framework and the standard Software Development Life Cycle (SDLC).

• Excellent technical writing and communication skills for authoring Standard Operating Procedures (SOPs).

Secondary (Good to Have):

• Experience with Computer Software Assurance (CSA) principles and Module Validation.

• Hands-on proficiency with Agile methodologies and tools such as Jira, ServiceNow, or HP ALM / automated testing tools.

• Exposure to regulatory audits, remediation activities, and data migration due diligence across GxP and Non-GxP environments.

• Familiarity with the adaptation of AI technologies within validated laboratory systems.

POSITION OVERVIEW

We are seeking an experienced Lab System Validation Engineer to join our team on-site in West Point, PA. This critical role focuses on ensuring that specialized laboratory software, automation equipment, and IT systems comply with global regulatory frameworks. The successful candidate will drive the end-to-end validation lifecycle using the V-model, safeguarding product quality and data integrity within GxP environments. You will play a foundational role in executing testing protocols, managing traceability matrices, and aligning technical operations with strict FDA and international standards.

ROLES & RESPONSIBILITIES

• Lead and implement a planned approach for CSV deliverables, validation plans, and migration due diligence across both GxP and Non-GxP areas.

• Author, review, and execute key validation documentation, including User Requirement Specifications (URS), Master Validation Plans (MVP), Testing Protocols (IQ/OQ/PQ), and Validation Summary Reports (VSR/TSR).

• Conduct validation and testing for process automation, laboratory automation, enterprise IT applications, and network infrastructure utilized in GLP, GMP, and GCP environments.

• Establish and maintain comprehensive Requirements Traceability Matrices (RTM) to ensure absolute alignment between compliance mandates and technical execution.

• Provide expert guidance and leadership regarding Regulatory Compliance and Quality Management requirements, ensuring all CSV artifacts consistently meet industry standards.

• Support regulatory audits and remediation activities, leveraging tools like Jira, ServiceNow, and HP ALM to track defects, manage testing workflows, and document system compliance.

BENEFITS

Medical | Dental | Vision | 401(k)

EEOC Compliance

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.