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Cleaning Validation Specialist II
at Renaissance LLC
Lakewood, NJ

Cleaning Validation Specialist II
at Renaissance LLC
Lakewood, NJ

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Description

Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.


Overview

This position is responsible for supporting the Cleaning Validation program requirements (i.e. included but not limited to equipment processes and procedures that support commercial and new R&D drug development activities for Renaissance, for all delivery systems manufactured in the Lakewood, NJ plant). This position is also responsible for generating and executing validation protocols and providing written reports.This is a salaried position and exempt from overtime pay

Responsibilities

1. Lead and perform risk assessments for determination of most critical cleaning conditions and acceptance criteria.
2. Review cleaning related method validations including specific and non-specific analytical methods, extraction studies, and recovery studies as applicable.
3. Write, review and execute cleaning development and Validation protocols including lab scale coupon studies, full scale spray coverage testing, and full-scale cleaning recipe and procedure development, as applicable. Perform validation activities within an aseptic and sanitary pharmaceutical environment.
4. Responsible for development final reports summarizing development data and risk assessments for determination of cleaning matrix, family approach, and critical cleaning parameters for validation.
5. Responsible for summarizing results and conclusions when writing final reports. Ensure final reports and study data is reviewed and approved in a timely manner after execution is completed.
6. Perform sampling for cleaning studies including collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing. Perform statistical analysis and evaluation of data to draw technical conclusions and make decisions.
7. Coordinate and schedule cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
8. Review of Master Batch Records. Ensure the content of the batch records meet the validated state of the process.
9. Lead the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.
10. Write and provide training on SOPs relevant to cleaning validation procedures. Evaluate cleaning procedures and revise with process improvements as necessary.
11. Train other personnel on rinse sampling and surface swab sampling.
12. Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, as they relate to validation and regulatory compliance issues.
13. Interfaces with other departments in support of cleaning validation activities. Participate in cross functional activities to support overall Validation department.
14. Additional duties as assigned.

Qualifications

Bachelor's Degree (BA or BS) in a Science, Engineering or other related field required.
Prefer at least 2 - 3 years of relevant experience in the pharmaceutical industry, preferably in a sterile manufacturing environment. Has knowledge and understanding of cGMP, ICH Q7 and FDA guidelines. Must have experience in the principles and approaches of product/equipment cleaning validation

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