1d ago

Manufacturing Manager Programs – Cleaning Validation

Us - North Carolina - Holly Springsmid

Manufacturing & ProductionManufacturing Manager

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Quick Summary

Requirements Summary

Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program. Provide technical support and domain expertise for commissioning, qualification,

Technical Tools

Manufacturing & ProductionManufacturing Manager

Manufacturing

Responsibilities

~1 min read

Doctorate degree OR

Master’s degree and 3 years of Validation or Engineering experience OR

Bachelor’s degree and 5 years of Validation or Engineering experience OR

Associate’s degree and 10 years of Validation or Engineering experience OR

High school diploma/GED and 12 years of Validation or Engineering experience

AND In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Requirements

~1 min read

Experience managing staff executing technical skills in a safe and compliant manner.

Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff

Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility

Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration

Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)

Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7

Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans