Validation Engineer III
About The Position
POSITION OVERVIEW: The Validation Engineer III ensures regulatory compliance by overseeing the validation of systems, equipment, and processes while managing the full lifecycle of Computer System Validation and cross-functional projects. This role plays a critical part in driving technical transfers, optimizing validation strategies, and leading continuous improvement initiatives to enhance operational efficiency. Additionally, the Senior Validation Engineer supports regulatory audits and inspections, proactively identifying and mitigating compliance risks to uphold the highest industry standards.
Requirements
- Bachelor of Science degree in a scientific or engineering discipline.
- 10 years Validation experience in the pharmaceutical or biotechnology industries.
- Advanced knowledge in current good manufacturing practices, CQV, sterilization validation, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and experience with Computer System and Cleaning Validation.
- Strong project management, problem-solving, and analytical skills with attention to detail and proficiency in Microsoft Office and Quality Management Systems.
Nice To Haves
- Certified Quality Engineer Preferred.
Responsibilities
- Ensures compliance by validating facilities, equipment, systems, and processes while authoring and approving commissioning and validation documents for sterile and non-sterile manufacturing.
- Manages the lifecycle of Computer System Validation, executes multiple protocols, and analyzes data to create reports, including deviations.
- Coordinates cross-departmental validation activities, tracks timelines and budgets, and drives technical transfers across sites.
- Leads continuous improvement through quality investigations, Corrective and Preventive Actions, Risk Assessments, Change Control, and staff training.
- Provides expertise during audits, manages contractors for Commissioning, Qualification, and Validation (CQV), and develops cleaning, sterilization, and process cycles.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
