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The Validation Engineer is responsible for overseeing and maintaining validation programs and insuring validation plans are properly implemented in compliance with corporate and regulatory requirements. The Validation Engineer is also responsible for site-wide compliance of the activities related to validation and performs work lead responsibilities.
The Validation Engineer reports into the Quality Assurance area and interacts daily with Quality and Manufacturing Engineers to insure compliance of the validation program. The incumbent conveys validation policies and procedures to regulatory bodies such as the FDA and other notified bodies. While monitoring and carrying out the validation program, the Validation Engineer makes improvements to the program as needed, and makes presentations to management when changes need to be made to the program or in association with key projects. The Validation Engineer works within the validation policies established by the company. Key to these policies is an understanding of the national and international organizations that define the quality requirements for validation. The Validation Engineer will report changes in these requirements and make changes to the validation policy where needed. The Validation Engineer may be assigned to special projects that are commensurate with his or her level of experience.
- Develops and oversees validation policies and procedures and ensures that they are in compliance with corporate, QSR, ISO, and other regulatory compliance requirements.
- Is responsible for developing and implementing validation policy and validation site plans.
- Coordinates and conducts risk assessments required by the validation program.
- Utilizes advanced statistical tools to determine sampling plans and to analyze data associated with validations activities.
- Oversees the validation program: schedules, files, and records.
- Performs and directs process validations, IQ, EOQ, POQ, PQ, and PPQ as well as lot validation activities as required.
- Administers validation training for the facility.
- Interfaces with Quality and Manufacturing Engineers to review processes, determine validation requirements, and coordinate the validation.
- Coordinates and performs testing relating to the validation.
- Works with suppliers, management, Engineers, and Manufacturing Associates in the resolution of quality problems associated with the validation program.
- Performs internal and external audits associated with validation activities.
- Writes validation protocols and reports as required.
- Oversees and directs the activities of the Validation Technicians.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES
- A bachelor’s degree in a scientific discipline or equivalent with a minimum of 2 years’ experience in a medical device or pharmaceutical environment OR an equivalent combination of education and experience is required.
- Knowledge of manufacturing processes and/or experience with validation work in medical device operations is required;
- A thorough understanding of the QSR and ISO regulatory environments is required;
- The ability to understand advanced mathematical concepts, e.g., probability, statistical inference, calculus and algebra is required;
- Organizational and time management skills including the ability to prioritize/understand how to deal with many conflicting priorities are a must;
- Knowledge of the use of basic computer software, including MS Office is a must: as is
- The ability to work independently; and
- Excellent verbal and written communication skills.