Kelly Science is seeking a Validation Engineer for a growing company located in Pennington, NJ.
Summary:
As a Validation Engineer, you will be responsible for ensuring that all manufacturing processes, systems, and equipment meets regulatory and industry standards from design through production.
Job Duties include:

• Creating and implementing validation protocols (IQ, OQ, PQ) for equipment, utilities, and processes.
  

• Developing, updating, and managing the site’s Validation Master Plan to ensure compliance with regulatory requirements and company standards.
  

• Analyzing validation data and prepare detailed reports documenting the validation process, findings, and recommendations.
  

• Identifying opportunities for process improvements, efficiency gains, and cost reductions in validation activities.
  

• Ensuring compliance with cGMP, FDA, EMA, and other relevant regulatory requirements.
  

• Maintaining comprehensive documentation for all validation activities.
  

• Working closely with Engineering, Quality Assurance, Quality Control, Manufacturing, and other departments to ensure seamless integration of validation activities into the overall project timeline.
  

• Providing training and support to other team members and departments regarding validation procedures and protocols.

Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related field. Advanced degree preferred.
  

• 3-5 years of validation experience in the pharmaceutical or biotechnology industry.
  

• Strong understanding of cGMP, FDA, EMA, ICH, and other relevant regulatory guidelines and standards.
  

• Proficient in developing and executing validation protocols and experience with various types of pharmaceutical manufacturing equipment and processes.
  

• Strong problem-solving and analytical skills with the ability to interpret complex data

Interested? Please apply today for immediate consideration!
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