Job Description

Perform design, development, manufacturing, or testing disciplines within the medical device industry. The Staff Validation Engineer will be responsible for executing and summarizing validation protocols and providing input on any validation activities related to the production of medical devices. This includes writing and executing IQ validation activities, OQ validation activities, PQ validation activities, TMV validation activities, CSV validation activities, and SAT validation activities; developing manufacturing work instructions and visual aids; and collecting data during validation and production activities to support the project and company objectives. Additionally, the role involves driving production development efforts for new products, analyzing and developing the manufacturing functions, capabilities, and facilities necessary for producing the customer’s product, and working with the Operations and Design team to verify and validate that the product in development meets regulatory and design requirements.

Responsibilities

• Provide technical engineering support for validations, write and execute IQ validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute OQ validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute OQ validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute PQ validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute TMV validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute CSV validation protocols, and supply data for the completion reports of the assigned validations.
• Provide technical engineering support for validations, write and execute SAT validation protocols, and supply data for the completion reports of the assigned validations.
• Ensure that the assigned validation activities are carried out in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP), and provide support in activities related to associated deviations.
• Be responsible for executing experiments during the pre-validation phase to determine the optimal operating configuration for maximum efficiency and product quality. Execute additional experiments as necessary to identify sources of variation in manufacturing processes, reduce unnecessary variations, and improve product quality.
• Demonstrate sufficient knowledge in validation skills, GMP, GDP, and the ability to carry out change control, quality change requests, and other disciplinary protocols as needed.
• Know and follow BEPC policies and procedures, as well as the work activities within your area of responsibility.
• Complete all training within the assigned timeframe.
• Follow all company safety policies and workplace safety precautions.
• Be responsible for the execution of Validation, including the creation of forms to record calibration records and preventive maintenance.
• Support the development of new product production.
• Be responsible for the analysis and development of manufacturing functions, capabilities, and facilities necessary for the production of the customer’s product.
• Work with the Operations and Design team to verify and validate that the product in development meets regulatory and design requirements.

Competencies

• Action-oriented.
• An energetic, forward-thinking, and creative individual with high ethical standards and a professional appearance.
• Possesses technical skills, analytical ability, good judgment, and an operational focus.
• An organized and self-directed team player.
• A trustworthy individual willing to share information.

Required Education and Experience

• Bachelors degree in Engineering.
• Advanced level of English (reading and writing) with advanced conversational skills in English.
• 7 to 10 years of experience in the manufacturing industry and/or 6 to 9 years of experience in the medical industry.

Preferred Experience

• Extensive knowledge in Six Sigma, DMAIC, and Kaizen.
• A Master’s degree in Science is an advantage.
• Strong skills in the development of Design of Experiments (DOE).
• Strong presentation skills before groups/clients.
• Extensive knowledge in Lean.
• Extensive knowledge in statistics.
• Strong skills in Project Management.

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