Description:

As a Cleaning Validation Engineer, you will be in charge of creating and executing cleaning validation protocols. Your role will focus on cleaning development, validation, and method validation. You will work on areas like autoclave sterilization, SIP/CIP of filling vessels and single-use systems, and COP parts washers. Although your primary focus will be aseptic filling areas, you may also support other GMP manufacturing and QC areas as needed.

Key Responsibilities:

• Develop and maintain SOPs and GxP documents for cleaning validation, including:
  • Material Transfer
  • Aseptic Practices in Filling & Isolators
  • Media Fill SOPs for Isolators
  • Cleaning procedures for Equipment Prep Areas, Filling, and Formulation
  • Gowning protocols for Formulation, Filling, and Equipment Prep
  • Filter Flush
  • Bulk and water sampling
  • Quality/Micro SOPs
  • Micro/EM SOPs
  • Process Validation/Master Plan
  • Cleaning Validation/Master Plan
• Ensure SOPs and GxP documents are clear, precise, and compliant with regulatory standards.
• Work with Quality Assurance, Manufacturing, and Engineering teams to ensure SOP accuracy.
• Review and update SOPs regularly to keep them current.
• Train staff on SOPs and best practices.
• Identify areas for improvement through gap analyses and risk assessments.
• Maintain organized records of all SOP activities.
• Keep up-to-date with industry trends and best practices.
• Lead efforts to improve SOP and GxP document processes.

Requirements:

• Bachelor’s degree in Science or Engineering.
• At least 5 years of experience in the pharmaceutical or biotech industry, with a strong focus on validation.
• Experience with Kaye validators and temperature data loggers for autoclave and Vessel SIP temperature mapping.
• Skilled in cleaning validation sampling, including swabbing and rinse sampling.
• Experience preparing and executing equipment qualification documents.
• Expertise in:
  • Sterilization Validation (autoclave and vessel SIP)
  • Cleaning Validation

Skills and Qualifications:

• Knowledge of Good Manufacturing Practices (GMP).
• Ability to work independently and communicate effectively.
• Team-oriented with a collaborative mindset.
• Familiarity with electronic records and signatures regulations.
• Capable of working in a complex, matrixed environment.
• Strong attention to detail and commitment to accuracy.
• Ability to manage multiple priorities and responsibilities with integrity and flexibility.