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6 days
Not Specified
Not Specified
$29.07/hr - $44.55/hr (Estimated)
<p>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.</p> <p>Responsibilities of the Cleaning Validation Engineer:</p> <ul> <li>Develop and execute cleaning validation protocols and reports for new equipment and facilities. </li><li>Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures. </li><li>Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan. </li><li>Conduct cleaning validation studies, including sampling, testing, and data analysis. </li><li>Investigate and resolve deviations and discrepancies related to cleaning validation. </li><li>Maintain accurate and detailed documentation of all cleaning validation activities. </li><li>Train personnel on cleaning validation procedures and best practices. </li><li>Stay current with industry trends, regulatory changes, and advancements in cleaning validation technologies. </li></ul> <p>Qualifications of the Cleaning Validation Engineer:</p> <ul> <li>Bachelor's degree in Engineering, Microbiology, Chemistry, or a related field. </li><li>Minimum of 3-5 years of experience in cleaning validation within the biopharmaceutical industry. </li><li>Strong knowledge of GMP regulations and cleaning validation guidelines. </li><li>Experience with greenfield projects and new facility build-outs is highly desirable. </li><li>Excellent analytical, problem-solving, and communication skills. </li><li>Ability to work independently and as part of a team in a fast-paced environment. </li><li>Proficiency in statistical analysis and data interpretation. </li></ul> <p>Compensation of the Cleaning Validation Engineer:</p> <ul> <li>$55-$70/hr, competitive hourly rate based on years of experience. </li><li>Benefits: Medical, Dental, Vision, 401k, and sick leave if required by law. </li></ul> <p>Keywords: Cleaning Validation, GMP, Biopharmaceutical, Quality Assurance, Risk Assessment, Protocol Development, Data Analysis, Regulatory Compliance, Greenfield Projects, Statistical Analysis.</p> <p>#LI-KI1 #LI-ONSITE</p> <p>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.</p>
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