Engineer, Validation Cover Letter

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

In my previous role, I was responsible for guidance to cross functional teams to ensure software quality objectives are met for medical device software.

Please consider my experience and qualifications for this position:

• Author technical documentation
• Experience in writing and executing commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols
• Able to physically enter tight spaces, climb ladders and work from heights
• Able to wear various types of respirators, protective clothing, and hearing protection
• Advanced computer knowledge including databases, process control, reporting, and project management
• Strong background in GMP
• Highly knowledgeable in the functional operation of equipment used in the production of active pharmaceutical ingredients
• Knowledgeable in computer programs including Microsoft Word and Excel

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

In my previous role, I was responsible for quality support for gas/liquid analyzer and medical device portfolio products.

Please consider my experience and qualifications for this position:

• Experience developing and debugging code in Windows AND/OR Linux environments
• Be able to demonstrate success in communicating plans, status, issues, concerns
• Demonstrated abilities in technical leadership and self initiative in work related projects
• Knowledge of cGMPs, pharmaceutical manufacturing methods and validation principles
• Work experience in equipment qualification and validation of computerized systems in the pharmaceutical environment
• Knowledge in pharmaceutical industry, image processing, Track & Trace and experience with coding standards (GS1, Brazil, China) is highly beneficial
• Fluent in French and preferably one other foreign language
• Has demonstrated an understanding of fundamentals of requirement specification, design, as they relate to infrastructure hardware and software

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

Previously, I was responsible for the generation and execution of cleaning validation support activities, such as: spray ball coverage testing, equipment characterization reports, protocol generation and review, and equipment sampling SOPs.

Please consider my experience and qualifications for this position:

• Knowledge on communication protocols (I2c, SPI, IIs, UART)
• Working knowledge of operating systems (Linux) is added advantage
• Automotive, Semiconductor domain experience
• Bachelors of Engineering (Electrical/ Mechatronics)
• Demonstrable experience of successfully managing complex validation projects, ideally including experience of successful validation of electronic Quality Management Systems (eQMS), Enterprise Resource Planning systems (ERP)
• Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing
• Test plan and test code development to address functional and integration requirements of the IP/SOC
• Good Software Architecture knowledge

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

Previously, I was responsible for technical leadership in leading/driving multi-functional Teams in active sustainability of existing Capital Equipment Medical Devices and Products.

Please consider my qualifications and experience:

• Knowledge of analog and digital video standards, an asset
• Programming skill in C, BASIC, JAVA, for the creation of MS-Windows GUIs/applications, an asset
• Customer biased focus
• Highly motivated, goal driven, self-starter
• Familiar with NI LabView and Test Stand
• Definition of engine build, test and instrumentation requirements
• Planning and delivery of product validation tests through both our onsite test facility and in-field testing
• Root Cause Analysis of failures

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

In the previous role, I was responsible for guidance on UX patterns, front end functional and non-functional testing, and coding and code review practices.

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:

• Experience with validated computer systems
• The good working knowledge of the Cell Culture and Bio production business or similar manufacturing process
• Working knowledge of validation within a GMP manufacturing environment
• Schedule validation studies involving manufacturing equipment to maximize utilization
• Prepare detailed, concise documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria
• Serve as the validation project manager representative on cross-functional project teams
• Prepare scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures
• Maintain close contact with New Product Development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation