Sr Validation Scientist with robust knowledge and execution of Good Manufacturing Procedures. Experience working in regulatory industries toprovides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
- Troubleshoot systemic validation issues.
- Validation engineering principles
- Change Control, Trackwise and Equipment Interphase (HMIs) systems
- Cleaning Validation Execution, Develop Protocols, Technical Reports, Validation Summary Reports and Validation Master Plans
- GMP production operations
- Documentation
Available to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of time
Requirements
- Masters degree and 3 years of directly related experience or Bachelors degree and5 years of directly related experience or Associates degree and 10 years of directly related experience
- FDA regulations
- Technical writing and presentation skills.
- Project management skills.
- Excellent written and oral communication skills in English and Spanish (Bilingual)
Available to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of time
Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience FDA regulations Technical writing and presentation skills. Project management skills. Excellent written and oral communication skills in English and Spanish (Bilingual) Available to work: 1st shift, 8am to 5pm, 80% of time, non-administrative shift, (2nd/3rd or weekend duty) to support execution of validation studies, 20% of time