Piper Companies is actively seeking a Cleaning Validation Engineer to join our team at a new manufacturing facility. The successful candidate will play a critical role in the development, implementation, and maintenance of cleaning validation processes, ensuring compliance with GMP standards and regulatory requirements. This is a Monday - Friday, traditional hours role located in the greater Raleigh, NC area.

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 3-5 years of experience in cleaning validation within the biopharmaceutical industry.
• 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:

• $55-$70/hr, competitive hourly rate based on years of experience.
• Benefits: Medical, Dental, Vision, 401k, and sick leave if required by law.

Keywords: Cleaning Validation, GMP, Biopharmaceutical, Quality Assurance, Risk Assessment, Protocol Development, Data Analysis, Regulatory Compliance, Greenfield Projects, Statistical Analysis.

• 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