Senior Engineer, Validation Cover Letter

Please consider me for the senior engineer, validation opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for validation support on process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Ortho’s validation policies and procedures.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Strong technical writing and communication skills in English
• Develop functional and System level analog and parametric tests for integrated microcontrollers and test chips
• Develop automated lab based testing of microcontroller for both digital and analog modules at the unit level and at the full chip level
• Functionally test prototype designs pre-silicon using FPGAs
• Develop performance tests for determining circuit margin and datasheet parameters
• Assisting in lab test bench design, configuration, and data collection activities
• Design or assist in the development of new testing infrastructure for use within the validation team
• Drive design recommendations to improve the validation process, such as enhancements to test software and hardware environments, lab equipment usage, and data management

Please consider me for the senior engineer, validation opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for quality training to site staff on validation procedures, validation science, measurement techniques/statistics, and GXP regulations.

Please consider my qualifications and experience:

• Optimize sterilization control processes, systems, and procedures to support growth in production volumes, addition of manufacturing sites, addition of sterilization locations and increase in product lines
• Knowledge of engineering design control systems, Agile preferred
• Experience in generating, reviewing, and executing validation and change control documents, authoring SOPs, Protocols (IQ, OQ, PQ) of Process Control Systems
• Understand and implement the SPC principles
• Preferred – CQE or Green Belt Certification
• In depth knowledge of 21 CFR Part 820 and other GxP (GMP, GLP, GDP) regulations
• Developing validation plan for individual analog IP's
• Developing Automation for analog IP's validation using LabVIEW

In response to your job posting for senior engineer, validation, I am including this letter and my resume for your review.

In my previous role, I was responsible for quality oversight of validation activities and on-site validation support (as needed) Participate in Project Team meetings and provide Validation compliance support to projects.

Please consider my qualifications and experience:

• Understanding of embedded microprocessor programming, design and internal architecture
• C and C++ programming languages
• Embedded C Programming (8 bit, 16 bit or 32 bit processors) and debugging
• Windows programming (Visual Studio/Visual C)
• Knowledge of personal computer architecture, I/O subsystems, address decoding, programmable peripheral ICs and keyboard controllers
• Comfortable with PC hardware, FPGA setup and testing
• Understanding the use of oscilloscopes, logic analyzers and other test equipment
• BE/ME in Electrical or Electronics Engineering

I am excited to be applying for the position of senior engineer, validation. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for pre-sales support to address both how our platform complies with applicable validation regulations as well as how our IT Validation solutions provide value and support for our clients.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Understanding of embedded microprocessor design and internal architecture
• Strong proficiency using oscilloscopes, logic analyzers and other test equipment
• Solid project organizational skills
• Bachelor of Science in Engineeringor Life Sciences
• Focus on meeting project schedules
• Keep supervisor and project managers informed of any validation or qualification issues
• Additional duties as deemed appropriate by the department head/designee
• Provide guidance to engineering teams, device reprocessing teams, and manufacturing teams in the selection of sterilization methods, sterilization cycles and locations, manufacturing locations, and the establishment of sterilization product families

I submit this application to express my sincere interest in the senior engineer, validation position.

In my previous role, I was responsible for interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSA’s, Validations and Qualifications.

Please consider my experience and qualifications for this position:

• Bring-up and validate analog modules for 16-bit Microcontrollers
• Good understanding of key analog macros like opamp, LDO, oscillator, bandgap, DAC
• Good experience in Post silicon validation
• Experience in hardware board debug including electrical debug and making necessary hardware improvements for validation
• Preferably have a good knowledge of Microcontroller Architecture
• With sense of responsibility, team work, self-initiated, motivating, ethic, customer oriented
• Knowledge of GSM/GPRS/EDGE/UMTS/LTE/TCP/IP specification/standards, prefer validation or development experience on AT commands and Embedded Applications, technical skill on generating test plan/test cases, management skill on keeping checking on the schedule and human resource allocation of the project
• Solid computer skill including C/C++, Microsoft Project, Words, Excel, PowerPoint