Equipment Validation Engineer

Description

• Write and review protocols and reports.
• Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
• Collaborate with R&D to ensure successful process development and technical transfer to Operations.
• Coordinate validation activities in support of assigned validation projects working closely with Quality Engineering, Engineering team members, Operations Excellence, Operations, etc.
• Recommend approval or failure of validation reports.
• Provide support to Engineering to ensure protocols are executed as intended.
• Maintain knowledge and comprehensive understanding of relevant Medical Device / pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation.
• Be a resource to other departments for product and process knowledge.
• Works with Operations Excellence, Operations & Quality to drive efficiency and implement future state processes.
• Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.

• Bachelor's degree in Engineering or Science Field.
• Five years relevant experience in medical device or pharmaceutical arena.
• Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation, and computer/automation systems.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
• Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
• Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
• Proficient in use of Microsoft Office Suite.
• Must be able to travel as needed.
• Performs other duties as assigned.