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Job Details

Skills

Manufacturing Operations
Inspection
URS
DS
DirectShow
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Manufacturing Operations
Inspection
URS
DS
DirectShow
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Summary

Job Summary:

The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Roles & Responsibilities:

uthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.

Education & Experience:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
Strong technical writing skills and ability to execute protocols with minimal supervision.
Nice to have: BMRAM and analytical lab instruments experience.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 18d63cc3aa65662e1ebcf5f2967a5ee3
Posted 30+ days ago

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