Sr. Validation Specialist
Dallas, TX
An industry leading Oncology focused company is looking for a Sr. Validation Specialist to join its rapidly expanding team! This newly created role will be integral in writing validation/ qualification protocols with an emphasis on Cleaning Validation. With a handful of products already approved and a strong pipeline of indications to follow this company is set for continued growth in 2020. If you are looking to advance your career in validation, don't hesitate to apply!
The Sr. Validation Specialist will be responsible for:
- Writing computer related system validation protocols, lyophilizer qualification protocols, and packaging equipment validation protocols
- Monitors the qualification and validations process to determine accuracy and reliability of equipment, systems, instruments and processes.
- Analyzes data summaries for validation protocols.
- Validation procedures.
- Providing technical advice on new equipment and systems and modification to existing equipment and systems to ensure validation/certification and servicing can be provided.
- Training personnel when needed.
- Recommending changes in policies and procedures, to management, to enhance the company's ability to conform to directives and regulations.
- Notifying and recommending to management course of action when critical instruments, systems or processes are found to be out of specifications.
The ideal candidate will have the following experience:
- Bachelor's degree in a scientific or engineering related discipline
- 2+ years of validation experience in sterile manufacturing environment
- Experience with Cleaning Validation