Validation Professional (Equipment and Cleaning)

Yoh has a contract opportunity for a VALIDATION PROFESSIONAL to join our client in Sellersville, PA.

JOB RESPONSIBILITIES:
- Prepare Cleaning Validation protocols, interim, summary, close-out and justification reports.
- Maintenance of the current Cleaning Validation site Matrix.
- Responsible for revising Matrix according to change control procedures.
- Perform statistical analysis on cleaning validation data to assist in setting alert limits and assess cleaning method capabilities.
- Calculate cleaning limits.
- Perform Cleaning Validation assessments for change control activities.
- Assist in tracking assessments and departmental sampling for on time completion.
- Prepare assessments for failure investigations.
- Prepare equipment sampling plans as needed.
- Prepare and update departmental SOPs as needed.
- Measure and calculate total product contact areas for new equipment.
- Assess product contact surfaces of manufacturing equipment for cleaning issues.
- Create equipment drawings for surface area calculations for Cleaning Validation activities.
- Evaluate cleaning/sanitization agents used in manufacturing.
- Evaluate manual and CIP cleaning procedures used in manufacturing.
- Execute cleaning validation, environmental monitoring and emission monitoring sampling as needed.
- Maintain and strive for Right the First Time in all work activities.
- Maintain regulatory compliance for training activities and follow all GMPs.
- Follows company safety policies and procedures, hazard Matrix and gowning procedures.

JOB QUALIFICATIONS:
- Minimum of three to five (3-5) years experience in Cleaning Validation or related field in the pharmaceutical (or relevant) industry.
- Familiar with statistical analysis and process capability analysis in order to assess cleaning method capabilities.
- Excellent verbal, written, computer (Microsoft Word, Excel, Visio/AutoCad, Stagraphics/Minitab), organizational, project management and attention to detail skills required.
- Working knowledge of cGMP and Cleaning Validation/Cross Contamination requirements
- Demonstrated professionalism and prepared to work in a team environment.
- Proven self-starter capable of organizing and managing multiple projects independently in a fast paced environment.
- Work hours may extend through 2nd and 3rd shifts depending on assignment schedule.

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Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources .

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