Validation Engineer Position Available In Bucks, Pennsylvania

Validation Engineer Job Employer Name:

ND Global Consulting Services Inc

SpiderID:

13850602

Location:

Newtown, Pennsylvania

Date Posted:

9/30/2024

Wage:

75816

Category:

Manufacturing

Job Code:

Number Of Openings:

1

Job Description:

Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Requirements Traceability Matrix, Validation Summary Reports, Standard Operating Procedures, Change Control Documentation, and Risk Assessment reports; also Manufacturing Process and Equipment
Managing and coordinating all aspects of the validation activities, including project planning, developing validation strategies, document development and document reviews.
Write and execute IQ and OQ protocols.
Conducting system compliance reviews.
Overseeing system change requests and associated documentation.
Managing documentation logs and document storage.
Maintaining SOPs pertaining to the Quality Management System.
Utilization of a risk-based approach (GAMP5) to determine the validation requirements.
Communicating with necessary vendors to ensure project requirements are being met.
Configuration specifications generation detailing the specific configuration of the systems / interfaces.
Project change control implementation in accordance with requirements, design and system changes.
Identify risks and clearly communicate them to project stakeholders.

Job Requirements:

Bachelor’s Degree is required in Biomedical Engineering or Biomedical Sciences.

Job Criteria:

Start Date:

09/30/2024

Position Type:

Full-Time Permanent

Years of Experience Required:

2

Education Required:

Bachelors

Overnight Travel:

Vacation Time:

Job Benefits:

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave Contact Information:

Contact Name:

Rashmi Kumari

Company Type:

Company:

ND Global Consulting Services Inc City:

Tampa State:

Florida Zip:

33647