Validation Manager
4 weeks ago
- Responsible for validation programs in support of GMP manufacturing
- Responsible for facility, utility and equipment qualification programs
- Responsible for QA role in process and assay validation programs
- Review or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipment
- Assume QA lead role in software validation
- Maintain and update validation master plans
- Execute validation protocols as required
- Oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing
- Supervisor, mentor validation staff with the goal of building a sustaining validation team
- Serve as the primary QA representative for interaction with internal function departments and contractor on validation activities
- BS/MS in life science or related field
- 12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering
- 10+ years experience in facility, utility, equipment, instrument validation
- Experience in biotechnology facility validation is required
- Familiar with GMP operational principles and practices
- QC experience helpful
- Works independently, self-motivated, and results oriented
-
Enterprise Model Validation Manager
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeKey Responsibilities:">Perform hands-on validations and reviews, write quality model validation reports, and provide model approvals.Collaborate with the Project Management Office (PMO) to maintain a viable model validation schedule, coordinate and oversee model validation, and review performed by the model validators to ensure timeliness, quality, and...
-
Validation Expert
1 day ago
Jersey City, New Jersey, United States beBee Careers Full timeJob Description:The primary responsibility of the Data Validation Specialist is to ensure that all data collected and processed within the organization is accurate, complete, and consistent.Main Responsibilities:Design and implement data validation procedures to prevent data errors and inconsistencies.Develop and maintain documentation of data validation...
-
Validation Consultant
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeSystem Validation ExpertWe are seeking an experienced system validation expert to join our team. In this role, you will be responsible for validating systems and performing CSV activities in GxP applications. Your expertise in GxP systems, SAP systems, product serialization systems, and MES systems is essential for this role.Responsibilities:Conduct thorough...
-
Risk Management Specialist
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeJob OverviewAs a Sr Model Validation Specialist, you will play an active role in the implementation of Model Risk Management framework by performing independent validation and review of Credit Risk and Stress Testing Models.
-
System Validation Professional
24 hours ago
Jersey City, New Jersey, United States beBee Careers Full timeGxP Compliance ConsultantThis position requires a CSV Engineer who can ensure GxP compliance and data integrity throughout the validation lifecycle. The successful candidate will have strong experience validating statistical programming environments, source code management systems, and Clinical Data Management Systems. They will also have a strong...
-
GxP Validation Expert
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeJob Title: GxP Assurance SpecialistSalary: $55hr - $60hrJob Description:System validation expertise in CSV activities and GxP related applications, such as SAP Systems, Product Serialization systems, and MES systems.Compliance with regulatory requirements ensured through comprehensive review of GxP systems.Required Skills and Qualifications:End-to-end...
-
Data Validation Specialist
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeJob Title: Data Validation SpecialistAbout the Role:We are seeking a highly skilled Data Validation Specialist to join our team. As a Data Validation Specialist, you will be responsible for ensuring the accuracy and quality of data in various systems.In this role, you will work closely with cross-functional teams to identify and resolve data validation...
-
Validation Expert
3 days ago
Jersey City, New Jersey, United States beBee Careers Full timeJob DescriptionThis role involves working with a professional recruiter who has in-depth knowledge of industry trends and market dynamics. The ideal candidate will have expertise in MS Windows client and server technologies, experience executing equipment qualification documents, and ability to interact effectively with laboratory, QA, and Facilities...
-
Risk Validation Specialist
2 days ago
Jersey City, New Jersey, United States beBee Careers Full timeAbout the RoleThis is a highly specialized role that requires expertise in risk model validation and governance.As a Risk Validation Specialist, you will be responsible for ensuring that our risk models are accurate, reliable, and meet regulatory expectations.Your main responsibilities will include:Model Development: Documenting risk model development to...
-
Senior Validation Engineer
3 days ago
Jersey City, New Jersey, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities:Support Client commissioning/validation for facility, utility, equipment, cleaning and process validation projects.Prepare and execute commissioning/validation lifecycle documents.Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or...