Sr. Process Engineer
This position is a key member of the Aziyo Biologics team and as such develops and assists with: a) new product introduction including technology transfer, commercial-scale process development, validation, and continuous improvements, b) design/selection of equipment, and c) technical studies in support of product characterization.
The responsibilities involve authoring and executing technical protocols and reports – including validation and product characterizations, organizing and analyzing data and test results, troubleshooting and ensuring accurate records of all activities. The Sr. Process Engineer also assists in the transfer of newly developed processes from the development stage to routine production in a manner that is consistent with the goals of Aziyo Biologics and with the Quality Management System. Critical to the role is ensuring compliance with regulatory standards, laws and requirements of requisite agencies by employing appropriate systems/processes.
Position reports to the Manager, Engineering.
Essential Duties & Responsibilities
• Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB) and others, as applicable, and adhere to standards and regulations to help the company lead the Biologics industries in quality practices.
• Develop and maintain a technical understanding of the company products and general biological and chemical systems utilized by Aziyo Biologics. Understand how the activities performed are controlled by and interact with the Quality System and how they affect the production of tissues.
• Generate and maintain the Company’s Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects to ensure processes are capable of consistently meeting their intended specifications and requirements. Develop and manage multiple validations with a focus on establishing robust process validations while achieving cost and timeline objectives.
• Design experiments and interpret experimental data generating informed analytical decisions to support validation activities.
• Develop, validate, and execute test methodology focused on understanding and/or measuring the biological systems within tissue products.
• Create, consult, and contribute to the specification and selection of equipment and processes to facilitate production and test processes.
• Facilitate the transfer of projects from Research and Development to routine testing.
• Support current manufacturing processes, equipment and tooling for continuous process improvements.
• Identify, analyze and correct manufacturing issues to ensure continuous supply of commercial products.
• Assist in capability development and certification programs within the organization to develop and train all levels of the organization in the use of OE processes, tools and methodologies.
Bachelor’s degree in Life Sciences or Engineering (or other related technical degree).
Experience and Skills
• Minimum of five years of experience in commercial scale biologics, tissue or device manufacturing or technical support
• Experience with development of IQ, OQ, PQ and SOPs.
• Experience with assay development, execution, and validation desirable.
• Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
• Ability to understand and design policies and procedures based on FDA, AATB, and OSHA regulations.
• Advanced PC, database and Microsoft Office skills.