Validation Manager

2 days ago


Jersey City, New Jersey, United States Primary Recruiting Services Full time
Job Summary

As a Validation Manager at Primary Recruiting Services, you will be responsible for leading the development and implementation of validation programs in support of GMP manufacturing. This includes facility, utility, and equipment qualification programs, as well as QA roles in process and assay validation programs. You will review and author validation-related documents, such as design specifications, URS, FAT, SAT, IQ, OQ, and PQ for utility and equipment. Additionally, you will assume QA lead roles in software validation, maintain and update validation master plans, and execute validation protocols as required. You will also oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing. As a supervisor and mentor, you will build a sustaining validation team and serve as the primary QA representative for interaction with internal function departments and contractors on validation activities.

Requirements

* BS/MS in life science or related field
* 12+ years of experience in the drug/biologics industry in GMP production environments in roles of validation/engineering
* 10+ years of experience in facility, utility, equipment, and instrument validation
* Experience in biotechnology facility validation is required
* Familiarity with GMP operational principles and practices
* QC experience is helpful
* Ability to work independently, self-motivated, and results-oriented
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