Validation Engineer I, Sterilization

4 weeks ago

Lakewood, United States GQR Full time

Job Title: Validation Engineer I, Sterilization

Status: Full-time direct hire, benefits available day 1.

Location: Lakewood, NJ

Compensation: $79,000 annual salary


Overview:

This position supports Equipment and Sterilization Validation processes, including Autoclave, SIP, tunnel, dry heat, and VHP studies, for commercial and new R&D drug development activities at the Lakewood, NJ plant. The role involves assisting with generating, reviewing, and approving protocols, deviations, and reports, as well as scheduling activities and providing feedback to internal and external customers. The individual will support qualification activities related to Process Performance Qualifications (PPQs) and ensure compliance with FDA and international regulations.


Responsibilities:

  • Technical Support: Assist with understanding and applying principles of sterilization and sanitization processes within the equipment validation scope.
  • Documentation: Help prepare and review validation protocols and reports for process equipment, utility systems, and environmental chamber
  • Technical Documents: Support the preparation and review of technical documents, including change controls, deviation investigations, validation protocols, and summary reports.
  • Validation Activities: Assist in performing validation activities within an aseptic pharmaceutical environment.
  • Regulatory Compliance: Support the implementation of applicable regulatory requirements, ensuring compliance with FDA, ISO, EMA, and other regulations.
  • Start-Up Activities: Provide technical support for temperature mapping and sterilization program start-up activities.
  • Requalification Support: Assist with periodic requalification activities for production equipment and systems.
  • Root Cause Investigations: Support root cause investigations related to sterilization and other related activities.
  • Data Analysis: Analyze manufacturing data using basic statistical principles to identify trends and potential areas for improvement.
  • Project Coordination: Help coordinate with cross-functional teams on projects aimed at improving productivity and quality.
  • Audit Support: Assist in equipment sterilization programs during internal and external audits, including regulatory inspections.
  • Process Assistance: Provide technical assistance for investigations into process/product issues and review design requirements as needed.
  • Customer Interaction: Support interactions with customers regarding transfer discussions, timelines, and project deliverables
  • Safety Compliance: Contribute to a safe working environment by adhering to safety rules and participating in safety-related activities.


Qualifications:

Bachelors or master’s degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree and a minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment is required.

Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH. Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.

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