validation engineer

This is dated 27/06/2009

Validation Engineer
Creation date : 06/27/2009 Last updated on 06/27/2009
Reference : VE62609
Hours : Full Time
Job(s) available(s) : 1
Experience required : 5-10 years
Education required : Bachelor
Working place : Lewisberry, PA
Weekly Shift : 1st
Job Summary:
The Validation Engineer reports to the Vice President, Quality Systems & Regulatory Affairs (VP, QS & RA) and is responsible for providing comprehensive support for production quality and continuous improvement initiatives and leading equipment/facility commissioning, installation and performance qualifications, and process/product validations. He/she will have overall responsibility for Unilife’s Master Validation program and will be responsible for working with R&D, equipment and material suppliers, and QA/RA on materials, components, equipment, and process qualifications and validations. The Validation Engineer develops, evaluates, and maintains reliability systems and standards pertaining to materials and techniques used in the design and production of medical devices, defines and provides specifications to engineering and production for determining the reliability of materials, components, processes and systems used in the manufacture of medical devices, and manages the development of new analytical tools and acceleration techniques to assure the early identification of potential problems with new materials, components, equipment and processes. In addition, the position will support quality in Operations by diagnosing and correcting improper quality control practices in production, and auditing production processes for deficiency identification and correction.
Essential Job Functions:
1. Maintains Master Validation Plan and required facility validation activities.2. Plans and implements product and process design verification and validation protocols.3. Writes and executes equipment installation, operational and performance qualifications and product validation protocols.4. Supports the validation of cleaning and sterilization processes.5. Develops and reviews internal test protocols and procedures, including experimental designs for process evaluation.6. Writes material, component, equipment, process, systems and cleaning validation requirements.7. Gathers statistical data and uses structured tools (FMEA, Cause & Effect) to define, measure, analyze, improve and control process variability and applies statistical sampling methodology towards acceptance of production and packaging equipment.8. Performs laboratory analytical methods for suitability by confirming repeatability and reproducibility of test results.9. Acts as validation representative with supplier and customer audits, as required.10. Supports senior management, immediate supervisor, QA/RA personnel and peers by performing any other tasks assigned or needed to support Operations and the safe and effective production of quality products.
Education/Experience Required:
The Validation Engineer must have a college degree (Bachelor’s degree in a science or engineering field required) with a minimum of 5 years experience in validation engineering or management in a FDA regulated industry with a thorough understanding of cGMPs for medical devices, 21 CFR part 820, and ISO 13485 standards for medical devices and quality management systems. Experience with drug cGMPs, 21 CFR part 210/211, highly desirable. Computer skills in MS Word, Excel and database programs required. Experience with electronic document control systems is desirable. Familiarity with and certification in Six Sigma, LEAN manufacturing or other vigorous quality control programs is highly desirable.
Physical/Mental Demands of Job:
This position is primarily office and computer driven. However, the ability to work in a clean room environment is an essential job function, as is the ability to communicate effectively orally and in writing with the entire workforce. The ability to perceive all aspects of the work environment, product and component samples and documentation is essential. This position requires attention to detail, excellent time and document management skills and the drive to complete and follow-through for completeness. The ability to handle multiple priorities in a fast changing work environment is essential, as is positive interaction with others. The Validation Engineer may be required to travel to perform on-site evaluation of external suppliers' validation protocols or provide training and assistance to supplier personnel as part of validation and qualification of suppliers' materials, equipment or processes. Excellent problem solving skills and a team approach to problem-solving and sharing responsibility is essential, as is the ability to teach validation principals to others. The Validation Engineer must be able to work on multiple projects with a minimum of supervision and meet established timelines. Strong interpersonal and communication (written and oral) skills are essential.Must be able to maintain self-control in challenging circumstances and be reliable in attendance and punctuality.