Technical Services – Cleaning Validation

Key Responsibilities

• Perform cleaning validation and cleaning verification sampling activities, including swab and rinse sampling of manufacturing and packaging equipment.
• Execute cleaning validation protocols, monitoring studies, and clean/dirty hold time studies.
• Capture and maintain accurate GMP documentation, laboratory notebooks, forms, protocols, and reports.
• Coordinate sampling activities with Manufacturing, Quality Control, and Quality Assurance departments.
• Complete equipment inspections and verify equipment readiness for sampling activities.
• Afford assistance in execution of cross-contamination assessments, cleaning investigations, and CAPA activities.
• Support maintenance of validated equipment lists and cleaning validation databases.
• Collect, organize, and trend cleaning validation data for ongoing monitoring programs.
• Assist in preparation, revision, and periodic review of SOPs and validation documents.
• Support regulatory inspections, client audits, and internal audits by providing cleaning validation documentation and technical support.
• Maintain compliance with site safety policies and GMP requirements.

  Education And Experience

  • Associates degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering Technology, or related scientific discipline preferred.
  • High school diploma/GED with relevant GMP pharmaceutical experience may be considered.
  • 1–3 years of experience in pharmaceutical manufacturing, validation, laboratory, or quality systems preferred.
  • Experience with cleaning validation, equipment qualification, sampling, or GMP documentation is desirable.

  Knowledge, Skills, And Abilities

  • Knowledge of cGMP, FDA, ICH, and pharmaceutical quality requirements.
  • Understanding of cleaning validation principles, equipment cleaning processes, and contamination control.
  • Ability to follow protocols and SOPs with a high degree of accuracy.
  • Strong documentation and data recording skills.
  • Proficiency with Microsoft Office applications.
  • Ability to work independently and collaboratively in a cross-functional team environment.
  • Strong organizational, communication, and problem-solving skills.

  Physical Requirements

  • Ability to work in manufacturing and warehouse environments.
  • Ability to wear required PPE.
  • Ability to climb ladders, access equipment platforms, and perform equipment swabbing activities.
  • Ability to lift up to 25 pounds and stand for extended periods during sampling activities.