Validation Analyst II (1106931)

Location: Philadelphia, PA

Salary: Depends on Experience

Description

Job Title: Validation Analyst II

Location: Philadelphia, PA

Type: Contract to Hire

Overview

The Validation Analyst II is responsible for managing moderate-risk validation projects with limited supervision. This role includes generating and executing validation protocols, supporting audits, and assessing validation requirements. This position does not have supervisory responsibilities.

Specialization Areas

• Process/Cleaning Validations
• HVAC/Utility Validations
• Computer Validations
  
  

Preferred Qualifications

• Process/Cleaning Validation Focus: Experience in packaging, pharmaceutical, biopharmaceutical, or medical devices. Ability to gown and work in active packaging environments.
• HVAC/Utility Validation Focus: Knowledge of HVAC systems, wiring diagrams, control design, calibration, and instrumentation.
• Computer Validation Focus: Associate’s degree in a related field and/or 1–3 years of relevant experience. Experience with computer systems impacting cGMP, cGXP, Annex 11, and PCI guidelines.
  
  

Key Responsibilities

• Execute validation activities to ensure compliance with regulatory and customer requirements.
• Prepare validation protocols, reports, summaries, and master validation plans for new product, system, or customer launches.
• Maintain validated processes and programs across multiple sites.
• Coordinate internal and customer approvals for validation documentation.
• Ensure validation documentation is complete, accurate, and properly closed.
• Prepare change control and validation history reports for audits.
• Participate in meetings and conference calls; communicate project goals and progress to the Validation Supervisor or Manager.
• Investigate validation deviations, document findings, and ensure corrective actions are implemented.
• Serve as the primary contact for quality validation activities.
• Review and interpret standards, procedures, and specifications related to validation protocols.
• Adhere to all relevant policies and regulations including cGMP, GCP, GAMP, 21 CFR, and Annex 11.
• Complete a required “Documentation Boot Camp” course within six months of hire.
• May require overtime and/or weekend work
  
  

Required Qualifications

• High School Diploma or GED and/or 3–5 years of related experience or training.
• College-level mathematical skills.
• Intermediate computer skills, including proficiency with various programs.
• Professional communication skills for effective participation in conversations.
• Ability to read and understand standard documents.
• Intermediate reasoning skills to solve problems using written, oral, or diagram instructions.
  
  

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Contact: amassad@judge.com

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