Senior Process Engineer

Position Overview.

This position is a key member of the Aziyo Biologics team and as such develops, plans and executes projects to improve the quality of products and support systems.

This position’s responsibilities involve analyzing quality metrics of existing products to identify target areas for improvement, to design experiments to test the validity of the identified relationships, and to define how changes will be implemented.  The Senior Process Engineer will also author protocols and reports to verify or validate products, equipment, and/or processes in order to support the launch of new products or changes to existing systems.  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 Director, Manufacturing Operations. 

Essential Duties & Responsibilities

• Develop and maintain a technical understanding of the company’s product offering and the controls in place to ensure quality products
• Collect and analyze data describing the quality metrics of existing products and identify potential areas of improvement
• Identify improvement opportunities and communicate the opportunity including cost impact to key stakeholders.  Drive implementation with planning and execution of identified process change deliverables.
• Define validation strategies incorporating project goals and compliance requirements.
• Execute validation studies (IQ, OQ, PQ) including writing protocols, coordinating, documenting and analyzing results, and generating a final validation report. Validation activities include, but are not limited to, equipment qualification, packaging qualification, process validation, cleaning/sterilization validation and computer related systems (i.e. spreadsheets) validation.
• Develop, validate, and execute test methodology focused on understanding and/or characterizing the biological systems within tissue products.
• Create, consult, justify and contribute to the selection of equipment and processes to facilitate production and product evaluation.
• Facilitate the transfer of projects from Research and Development to routine production.
• Mentor engineer(s) with less experience aiming to grow knowledge and further career growth.
• 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.
• 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.

Education

Bachelor’s degree in life sciences or engineering field.

Experience and Skills

Work Experience Required:

• Minimum of four years of experience in a biotech or pharmaceutical setting, preferably in process development or quality engineering.
• 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.

Specialized Skills, Knowledge:

• Ability to understand and design policies and procedures based on FDA, AATB, and OSHA regulations.
• Advanced PC, database and Microsoft Office skills.
• Highly skilled at troubleshooting and problem solving.
• Extensive knowledge of statistical analytical methods using JMP, Minitab, or similar required.
• Experience with analytical techniques such as mechanical testing, biological assays (cell and protein quantification methods) and aseptic techniques required.
• Experience with validation methodology required.

We are an equal opportunity employer committed to affirmative action and diversity in our workforce – M/F/D/V