Cleaning Validation Specialist

2 weeks ago

Milford, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • List primary duties and responsibilities for this position in order of importance and time spent. Include supervisory responsibilities. Focus on responsibilities rather than projects. Avoid being vague or listing many minor duties.
  • Demonstrate a solid understanding, knowledge, skills set and experience in Cleaning Fundamentals (i.e., Regulatory Issues & Cleaning Validation Requirements; Cleaning Principles, Cleaning Strategies; Risk Assessments, Analytical/Sampling Methods, etc.).
  • Design, plan and execute experiments (i.e., cleaning process design / development) to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.
  • Generate and modify cleaning procedures / work instructions for new products / new process and/or existing manufacturing equipment.
  • Lead and participate in the initial cleaning validation activities' deliverables (i.e., scheduling, assessment; training; documentation; execution; issue resolution; reporting, etc.).
  • When required, investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
  • Audit current cleaning processes and ensure compliance with cGMP, Site/Global quality policies and current industry standards.
  • Perform routine verification studies (continued process verification, CPV).
  • Maintain the validated status of cleaning processes.

Requirements:

  • Minimum education - Bachelor's or Master degree in Life Sciences, Pharmacy, Chemistry; Biology or related Engineering discipline (Chemical Engineering).
  • Minimum of 5-7 years of professional hands-on and direct cleaning validation experience (CIP; COP; Manual Cleaning) in pharmaceutical / biotech industries.
  • Extensive knowledge of various cleaning techniques and technology.
  • Broad knowledge of regulatory compliance and its relation to cleaning of product contact equipment in the biopharmaceutical manufacturing environment.
  • Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
  • Excellence in writing, reviewing and executing cleaning verification / validation protocols; design of experiments (DOE); risk assessment and technical reports.
  • Strong project leadership skills.
  • Proven assessment, analytical and problem-solving skills.
  • Working experience in adopting ASTM E2500 standards.
  • Personnel communications, encouraging and achieving the right amount of effort from staff for completion of daily activities.
  • Excellent technical writing ability for technical and compliance reports or submission.
  • Understand potential risk areas / shortfalls to deliver validations right first time.
  • Ability to organize and execute multiple tasks in a fast-paced environment.
  • Advanced skills in Microsoft Office.
  • Excellent oral and written communication skills in English.
  • Must be able to work to meet deadlines and use problem solving skills.
  • Current member of ISPE in Cleaning Validation.
  • Expertise and experience with the contract development manufacturing and sterile / aseptic operations.
  • General knowledge of process flows and personnel flows in the biopharma manufacturing environment.
  • Demonstrate skills in troubleshooting critical process or equipment issues.
  • Proven mechanical aptitude preferred
  • Technology transfer / New Product/Process Introduction
  • Strong communication, prioritization, and organizational skills, attention to details.
  • Good understanding of Process Validation requirements and life science concept is a plus.

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