Piper Companies is looking for a Cleaning Validation Engineer that will play a critical role in the development, implementation, and maintenance of cleaning validation processes for a brand new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best practices. The successful candidate will ensure that all cleaning procedures are validated and compliant with GMP standards.

Responsibilities of the Cleaning Validation Engineer:

• Develop and execute cleaning validation protocols and reports for new equipment and facilities.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigate and resolve deviations and discrepancies related to cleaning validation.
• Maintain accurate and detailed documentation of all cleaning validation activities.
• Train personnel on cleaning validation procedures and best practices.
• Stay current with industry trends, regulatory changes, and advancements in cleaning validation technologies.

Qualifications of the Cleaning Validation Engineer:

• Bachelor’s degree in Engineering, Microbiology, Chemistry, or a related field.
• Minimum of 5+ years of experience in cleaning validation within the biopharmaceutical industry (more than 5 years preferred).
• Strong knowledge of GMP regulations and cleaning validation guidelines.
• Experience with greenfield projects and new facility build-outs is highly desirable.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency in statistical analysis and data interpretation.

Compensation of the Cleaning Validation Engineer:
Pay Range: $60-$80/hr depending on experience
Benefits: Health, dental, vision, PTO, and sick leave as required by law. Also, you’ll be part of a team working on what will be the largest CDMO of its kind.
Application Details: This job opens for applications on 4/14. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: validation, engineer, cleaning validation, GMP, biopharmaceutical, greenfield projects, statistical analysis, quality assurance, manufacturing, engineering

• Develop and execute cleaning validation protocols and reports for new equipment and facilities.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigate and resolve deviations and discrepancies related to cleaning validation.
• Maintain accurate and detailed documentation of all cleaning validation activities.
• Train personnel on cleaning validation procedures and best practices.
• Stay current with industry trends, regulatory changes, and advancements in cleaning validation technologies