Validation Engineer
Austin, Texas
Employer: Azzur Group
Industry:
Salary: Competitive
Job type: Full-Time
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a CQV Engineer at Azzur Group, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of processes, systems, and equipment for our clients in the Life Sciences sector. We are seeking candidates at various experience levels to support our growing pipeline of projects. Whether you are a seasoned professional or just starting your career in CQV, we welcome diversity in experience and expertise. The following is a short list of the typical responsibilities and deliverables of any given project.
Qualifications
#LI-KR1
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a CQV Engineer at Azzur Group, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of processes, systems, and equipment for our clients in the Life Sciences sector. We are seeking candidates at various experience levels to support our growing pipeline of projects. Whether you are a seasoned professional or just starting your career in CQV, we welcome diversity in experience and expertise. The following is a short list of the typical responsibilities and deliverables of any given project.
- Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.
- Contribute to the development and revision of Standard Operating Procedures (SOPs) related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.
- Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.
- Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.
- Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
- Identify and assess risks associated with CQV activities and develop mitigation strategies.
Qualifications
- Required Education: Bachelors degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Science related field
Preferred Education: Bachelors or masters degree in Bioengineering, Biomedical Engineering, Mechanical
Engineering, Chemical Engineering, or Science related technical degree preferred. - 3-5 years experience of validation and/or quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Knowledge in the areas of validation lifecycle documentation (URS, System Classification, Risk
Assessment, Design Reviews), and Validation Protocols (IQ, OQ, PQ, PV, CSV,
requalification/periodic reviews) etc. - Preferred experience:
- 3-5 years project experience with authoring and executing validation protocols of manufacturing process equipment and QC lab equipment, automation/computerized systems, and/or utilities and facilities
#LI-KR1
Created: 2024-09-01
Reference: PrC1eXFsBLws
Country: United States
State: Texas
City: Austin
ZIP: 78749
Similar jobs:
-
Senior Validation Engineer
Azzur Group in Austin, Texas -
System Validation Engineer, System Validation Engineer
Amazon in Austin, Texas -
Silicon Validation Software Engineer: Embedded and Low-level Programming
Apple in Austin, Texas -
iPhone Hardware Systems Validation Engineer
Apple in Austin, Texas -
Validation Engineer III—Sterilization
ICU Medical in Austin, Texas -
Silicon Validation Software Engineer- GPU IP Validation and Integration
Apple in Austin, Texas -
Product, Test or Validation Engineering Intern
Texas Instruments in Dallas, Texas💸 $45.00 per hour -
Software Engineer: Validation of Crypto and Security IPs
Apple in Austin, Texas -
Career Accelerator Program - Product, Test & Validation Engineer
Texas Instruments in Dallas, Texas💸 $90000 - $125000 per year -
System Verification and Validation Engineer - Space Systems
Oceaneering in Houston, Texas -
System Verification and Validation Engineer
Jacobs in Houston, Texas -
Silicon Validation Engineer
Apple in Austin, Texas -
SoC Performance Validation Engineer, Platform Architecture
Apple in Austin, Texas -
iPhone/iPad Hardware Validation Engineer
Apple in Austin, Texas -
Post-Silicon Validation Engineer
Amazon in Austin, Texas💸 $128600 per year -
Silicon Validation Software Engineer- GPU IP Validation and Integration
Apple in Austin, Texas -
iPhone Hardware Validation Automation Engineer
Apple in Austin, Texas -
Silicon Validation Engineer
Apple in Austin, Texas -
I3C Post Silicon Validation Engineer - Senior
Apex Systems in Austin, Texas -
Post-Silicon Validation Engineer
Amazon in Austin, Texas💸 $128600 per year