Process Validation Engineer

Micropulse; Fort Wayne (IN); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Micropulse is seeking a Process Validation Engineer to oversee verification and validation testing across our medical device manufacturing processes. You will contribute to establishing new processes and their parameters, and you will document each validation phase while maintaining strict work instructions for validated processes.

The role requires ensuring evidence of consistency and repeatability through testing, adapting processes to new standards, and monitoring controls.

Qualifikationen

• Associate degree in manufacturing or quality engineering or equivalent experience.
• Manufacturing environment experience required.
• ISO 13485 experience preferred.

Aufgaben

• Perform verification and validation testing on processes used in medical device manufacturing.
• Aid in establishment of new processes and parameters for those processes.
• Compose documentation for each phase of validation.
• Maintain work instructions for validated processes.
• Provide evidence of repeatability for processes through parameter testing.
• Adapt processes to meet new requirements, standards, or criteria.
• Monitor the control of validated processes.
• Conduct DOE studies to develop validated parameters.
• Develop and execute Design of Experiments.
• Troubleshoot complex validation issues and apply engineering principles to process modifications.

Kenntnisse

Validation principles

Communication skills

Independent work

Attention to detail

Office equipment operation

Ausbildung

Associate degree in manufacturing or quality engineering

Four-year degree preferred

Jobbeschreibung

The Process Validation Engineer will report directly to the Director of Quality. This position will have primary responsibility for performing verification and validation testing activities throughout the facility.

Essential Duties and Responsibilities

• Perform verification and validation testing activities on processes used in medical device manufacturing
• Aid in the establishment of new processes and the parameters associated with the processes
• Compose documentation for each phase of validation
• Aid in the establishment and maintenance of work instructions for validated processes
• Provide evidence of the consistency/repeatability for processes through testing of parameters
• Adapt processes to meet new requirements, standards, and/or criteria
• Monitor the control of validated processes
• Maintain the Material Contacts list for the facility
• Conduct DOE studies to develop parameters for validated processes
• Research and provide input on new processes and technologies
• Develop and execute Design of Experiments
• Develop validation protocols and perform testing
• Troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process modifications

Education and/or Experience

• Associate degree in manufacturing or quality engineering, or equivalent experience, required; a four-year degree is preferred
• Experience in a manufacturing environment required
• ISO 13485 experience preferred

Knowledge, Skills, & Abilities

• Knowledge of basic validation principles
• Strong written and verbal communication skills
• Ability to adapt to workload and work independently
• Strong attention to detail
• Ability to operate office equipment, including computers, copiers, fax machines, and phones Environmental & Physical Demands
• Manufacturing environment. May require sitting or standing for long periods of time
• Occasional exposure to loud noise
• May require long periods of time in front of a computer

Note: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time