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.
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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.