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Validation Engineer - Rengerative Medical Devices

Collagen Matrix Allendale, NJ

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Position Summary/ Objectives The Validation Engineer will be responsible for supporting the manufacturing operation by evaluating and trouble-shooting manufacturing processes with the goal of continuously improving safety, productivity, yields, process reliability and manufacturing costs. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality. Essential Job Functions: Evaluate and score risks associated with manufacturing processes and prepare detailed reports identifying chance of failures and risk-control measures in place. Identify areas of concern and possible improvement opportunities Prepare process validation protocols, reports and plans in order to launch new products and/or upgrade existing manufacturing processes. Track completion of annual Non-routine testing for all active product lines. Ensure testing is completed on a timely basis Manage Sterilization validation program and ensure that dose audits and testing is completed per required schedule. Prepare all required reports. Perform investigations to determine the root cause for process failures and prepare/manage Corrective Action plans to prevent recurrence. Gather, track and statistically analyze process data Assist with various ad hot projects and other duties as assigned Competencies: Meaningful Innovation Ownership/Accountability Pace/Efficiency Teamwork/Collaboration Integrity/Ethical Practice Resilience/Grit Education, Experience and Certification: Bachelor’s degree in Chemical or BioMechanical Engineering 0-5 years of industrial experience Experience in a regulated industry is a plus, although not required. This includes work in the Medical Device, Pharmaceutical or an ISO 9000+ registered company Excellent verbal and written communication and ability to work in a team environment Employment Type: Full Time Years Experience: Less than 1 year Bonus/Commission: Yes

Collagen Matrix


Allendale, NJ
07401 USA



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