Overview
On Site
Full Time
Skills
Life Sciences
Computer Science
Pharmaceutics
Medical Devices
IQ
OQ
PQ
Risk Assessment
Migration
Documentation
Test Scripts
Microsoft Windows 7
Microsoft Operating Systems
Microsoft Windows
GxP
Regulatory Compliance
Communication
Analytical Skill
Conflict Resolution
Problem Solving
Quality Assurance
Job Details
Roles & Responsibilities:
- Bachelor's degree in engineering, Life Sciences, Computer Science, or a related field.
- Minimum of 3-5 years of experience in validation within the pharmaceutical, biotech, or medical device industries.
- Develop and execute validation protocols (IQ, OQ, PQ) for the migration of lab instruments from Windows 7 to Windows 10.
- Conduct thorough assessments of existing lab instruments to identify compatibility issues and ensure all instruments are supported on Windows 10.
- Ensure all migration activities comply with GxP regulations and maintain system validation throughout the process.
- Perform risk assessments and develop mitigation strategies to address potential issues during the migration.
- Maintain detailed documentation of the validation process, including validation plans, test scripts, and validation reports.
- Work closely with IT, QA, and lab teams to coordinate validation activities and address any issues that arise.
- Proficiency in Windows 7 and Windows 10, knowledge of GxP compliance, experience with lab instruments, and strong troubleshooting skills.
- Excellent verbal and written communication skills, with the ability to explain technical concepts to non-technical users.
- Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving issues.
- Experience with automated validation tools and software.
- Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.