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.
#LI-KI1 #LI-ONSITE
Application Details: This job opens for applications on 4/7. Applications for this job will be accepted for at least 30 days from the posting date.