Validation Engineer - 259725

Medix™; North Dakota; Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Medix Staffing Solutions, Inc. seeks an experienced Validation Engineer to support a biotechnology/pharma manufacturing partner. The role focuses on equipment qualification, sterile filtration qualification, and aseptic manufacturing within a regulated environment.

The engineer will lead PQ activities, support APS, manage PUPSIT and EU GMP Annex 1 compliance, and coordinate with external labs and cross-functional teams to ensure timely validation milestones.

Qualifikationen

• Experience in validation engineering within pharma/biotech manufacturing.
• Hands-on equipment qualification and PQ execution.
• Knowledge of sterile filtration systems and sterilizing-grade filter assemblies.
• Familiarity with PUPSIT requirements and EU GMP Annex 1 guidelines.
• Experience supporting or leading APS activities.
• Experience developing, executing, and revising validation protocols and controlled documentation.
• Ability to coordinate with external contract testing laboratories and manage sample testing activities.

Aufgaben

• Filtration System Validation: Qualification and validation of sterile filtration systems with emphasis on PUPSIT and EU GMP Annex 1 compliance.
• PQ: Develop and execute PQ protocols to evaluate process performance and establish acceptable operating parameters.
• Aseptic Process Simulation (APS): Coordinate APS execution and ensure effectiveness of aseptic controls.
• Validation Documentation: Update validation master plans, batch records, protocols, and other controlled documentation.
• Contract Laboratory Coordination: Coordinate sample testing with external labs and verify sample suitability.
• Cross-Functional Collaboration: Work with manufacturing, quality, engineering, and validation teams to troubleshoot issues and meet milestones.
• Regulatory Compliance: Ensure all activities align with GMP requirements and internal procedures.

Kenntnisse

Validation engineering

PQ execution

Aseptic processing

GMP documentation

Regulatory compliance

Cross-functional collaboration

Communication

Tools

Sterilizing-grade filters

Filtration skids

Jobbeschreibung

6-Month Contract | Potential for Extension

Position Overview

We are seeking an experienced Validation Engineer to support a leading biotechnology and pharmaceutical manufacturing organization specializing in the development and production of advanced biologic products and life-changing therapies. This individual will play a key role in supporting equipment validation, sterile filtration qualification, and aseptic manufacturing processes within a regulated manufacturing environment.

The primary focus of this position will be the qualification of a new filtration system, including Pre-Use Post-Sterilization Integrity Testing (PUPSIT) and compliance with EU GMP Annex 1 requirements. The Validation Engineer will lead Performance Qualification (PQ) activities, support Aseptic Process Simulation (APS), and ensure validation documentation and testing activities are properly executed.

Key Responsibilities

• Filtration System Validation: Support the qualification and validation of sterile filtration systems, with an emphasis on PUPSIT requirements and EU GMP Annex 1 compliance to verify the integrity of sterilizing-grade filter assemblies.
• Performance Qualification (PQ): Develop and execute PQ protocols to evaluate process performance, specifically assessing material loss volumes throughout the filtration process and establishing acceptable operating parameters.
• Aseptic Process Simulation (APS): Serve as a primary point of contact for APS execution, coordinating simulation activities and ensuring processes adequately demonstrate the effectiveness of aseptic manufacturing controls.
• Validation Documentation: Execute updates to validation master plans, batch records, protocols, and other controlled documentation to support ongoing qualification and compliance activities.
• Contract Laboratory Coordination: Work directly with external contract testing laboratories to coordinate sample testing, verify sample suitability, review testing requirements, and ensure accurate and reliable results.
• Cross-Functional Collaboration: Partner with manufacturing, quality, engineering, and validation teams to troubleshoot issues, support testing activities, and ensure project milestones are achieved.
• Regulatory Compliance: Ensure all validation and qualification activities align with applicable GMP requirements, industry standards, and internal quality procedures.

Qualifications

• Previous experience in validation engineering within a pharmaceutical, biotechnology, or biopharmaceutical manufacturing environment.
• Hands-on experience with equipment qualification and Performance Qualification (PQ) execution.
• Knowledge of sterile filtration systems and sterilizing-grade filter assemblies.
• Familiarity with PUPSIT requirements and EU GMP Annex 1 guidelines.
• Experience supporting or leading Aseptic Process Simulation (APS) activities.
• Experience developing, executing, and revising validation protocols and controlled documentation.
• Ability to coordinate with external contract testing laboratories and manage sample testing activities.
• Strong understanding of GMP documentation practices and regulatory compliance.
• Excellent communication, organizational, and cross-functional collaboration skills.

Preferred Experience

• Experience supporting biologics manufacturing or sterile drug product manufacturing.
• Background working with filtration skids, sterilizing-grade filters, and aseptic processing equipment.
• Experience with material loss assessments, process qualification, and filtration validation.
• Familiarity with validation master plans, batch records, and process validation documentation.
• Experience working within a regulated manufacturing environment operating under FDA and/or EU GMP guidelines.