Quality Engineer - Validations Job
If this is a scam...
Mark as SPAM
Thank you for helping!...
Undo
Employer: ND Global Consulting Services Inc
SpiderID: 13988738
Location: Orchard Park, New York
Posted: 5/2/2025
Wage: 85342
Priority Review Date: 7/31/2025
Job Code / NOC / SOC:
Category: Biotech
Job Description:
Quality Engineer - Validations is needed to perform the following duties:
· Preparing and executing validation deliverables such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ):
o Perform installation qualification: the equipment to be installed according to manufacturers’ requirements, which requires a thorough understanding of the equipment design and functioning.
o Perform operational qualification.
o Perform performance qualifications to mimic the performance of the equipment and the process in a production atmosphere.
· Supporting the development and execution of Test Method Validation (TMV) protocols and reports:
o Develop test methods.
o Generate test method validation protocols and execute them.
·Defining inspection requirements based on process capability studies.
o Measure specific data using appropriate equipment.
* Use the measured data to understand the capability of the processes using statistical processes and defining inspection requirements.
· Collaborating with cross-functional teams to ensure validation activities align with regulatory and quality standards.
· Documenting results and maintaining records in accordance with company procedures and applicable regulations.
· Preparing and executing validation deliverables such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ):
o Perform installation qualification: the equipment to be installed according to manufacturers’ requirements, which requires a thorough understanding of the equipment design and functioning.
o Perform operational qualification.
o Perform performance qualifications to mimic the performance of the equipment and the process in a production atmosphere.
· Supporting the development and execution of Test Method Validation (TMV) protocols and reports:
o Develop test methods.
o Generate test method validation protocols and execute them.
·Defining inspection requirements based on process capability studies.
o Measure specific data using appropriate equipment.
* Use the measured data to understand the capability of the processes using statistical processes and defining inspection requirements.
· Collaborating with cross-functional teams to ensure validation activities align with regulatory and quality standards.
· Documenting results and maintaining records in accordance with company procedures and applicable regulations.
Job Requirements:
Bachelor's Degree is required in Mechanical Engineering or Engineering Management.
Job Criteria:
Start Date: 05/12/2025
Position Type: Full-Time Permanent
Experience: 3
Education: Bachelors
Travel:
Vacation:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Rashmi Kumari | Type: Staffing Agency |
| Company: ND Global Consulting Services Inc | |
| Web Site: https://www.ndgcs.com | |