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Cleaning Validation Specialist

2 months ago

Lakewood, New Jersey, United States Renaissance LLC Full time
About the Role

Renaissance LLC is seeking a highly skilled Cleaning Validation Associate to join our team. As a key member of our Cleaning Validation program, you will play a critical role in ensuring the quality and compliance of our cleaning processes.

Key Responsibilities
  • Technical Support: Provide technical expertise in Cleaning Validation principles and practices to support development, verification, validation, and monitoring activities.
  • Data Analysis: Assist in the development of Design of Experiments (DOEs) and statistical sampling plans, perform basic statistical analysis, and evaluate data to support technical decisions.
  • Batch Records: Review Master Batch Records to ensure alignment with validated cleaning processes and support manufacturing schedules.
  • Validation Activities: Perform cleaning validation tasks, such as sampling, within a pharmaceutical environment, ensuring adherence to aseptic and sanitary conditions.
  • Regulatory Compliance: Implement and follow applicable regulatory requirements, including FDA, ISO, and EMA guidelines, to ensure compliance.
  • Resource Management: Assist in scheduling and planning resources to support cleaning validation efforts and meet project timelines.
  • Team Communication: Communicate expectations and updates to the Cleaning Validation team and report on team progress and priorities to Validation management.
  • Customer Interaction: Support interactions with customers regarding transfer discussions, timelines, and project deliverables.
  • Time Management: Manage personal tasks effectively and assist in maintaining team timelines.
  • Program Planning: Contribute to the generation and maintenance of site program plans and the validation master plan.
  • Root Cause Analysis: Collaborate with area owners to identify potential root causes and recommend preventive and corrective actions.
  • Regulatory Discussions: Assist in discussions with regulatory agencies, quality assurance, or clients as needed.
  • Process Review: Support the review of SOPs and internal processes to ensure compliance with quality standards and cGMP regulations.
  • Compliance and Improvement: Identify potential compliance issues and areas for improvement.
Requirements
  • Education: Bachelor of Science degree in a Science, Engineering, or related field required. Advanced education preferred.
  • Experience: Familiarity with current industry practices and guidelines, including those required by the FDA, ISO, EU, and ICH.
  • Skills: Strong analytical and problem-solving skills, excellent communication and teamwork skills, and ability to work in a fast-paced environment.