Demo

Cleaning Validation Specialist

United Consulting Hub
Metuchen, NJ Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/6/2025

Job Title : Cleaning Validation Specialist (Entry-Level)

Job Overview :

We are looking for an enthusiastic and detail-oriented Cleaning Validation Specialist to join our pharmaceutical team. In this entry-level role, you will be responsible for supporting the cleaning validation processes in pharmaceutical manufacturing, ensuring that equipment and production areas meet regulatory standards for cleanliness and contamination control. This role provides an excellent opportunity to gain experience in the pharmaceutical industry while ensuring compliance with Good Manufacturing Practices ( GMP ) and other regulatory requirements.

Key Responsibilities :

  • Assist in Cleaning Validation Studies : Support the planning, execution, and documentation of cleaning validation studies for pharmaceutical manufacturing equipment and production areas.
  • Sampling and Testing : Perform surface sampling and assist in microbiological and chemical testing to verify that cleaning procedures are effective.
  • Documentation : Prepare and maintain detailed cleaning validation protocols, reports, and test results in accordance with GMP, FDA, and other regulatory requirements.
  • Develop Cleaning Procedures : Assist in the development, review, and approval of Standard Operating Procedures ( SOPs ) for cleaning processes and protocols.
  • Support Equipment and Facility Qualification : Assist in the qualification of cleaning processes, ensuring that cleaning methods are validated for specific equipment and manufacturing conditions.
  • Data Analysis : Analyze cleaning validation data, identify trends, and report results to senior team members for review.
  • Compliance : Ensure all cleaning validation activities comply with industry regulations, including FDA, EMA, and other relevant guidelines for cleaning validation and contamination control .
  • Continuous Improvement : Contribute to continuous improvement initiatives by identifying opportunities to optimize cleaning processes and validate new cleaning technologies.
  • Cross-Functional Collaboration : Work closely with Quality Assurance, Manufacturing, and Engineering teams to ensure alignment on cleaning processes, validation requirements, and best practices.
  • Training and Development : Participate in training sessions to understand cleaning validation standards and regulations, while expanding your knowledge in pharmaceutical manufacturing processes.

Requirements :

  • Bachelor's degree in Pharmaceutical Sciences , Chemical Engineering , Biology , Chemistry , Life Sciences , or a related field.
  • Basic knowledge of Good Manufacturing Practices (GMP) , cleaning validation , and pharmaceutical regulations .
  • Strong attention to detail, organizational skills, and ability to follow established protocols.
  • Excellent written and verbal communication skills to document and report findings clearly.
  • Ability to work effectively in a collaborative, team-oriented environment.
  • Strong problem-solving skills and a proactive approach to identifying issues.
  • Willingness to learn and grow within the pharmaceutical industry.
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