Manager, Process Engineering.
Position Overview.
Who We Are
We’re a team with a shared purpose to bring innovative solutions to physicians and patients around the globe. What we do or don’t do each day affects the lives of patients and that’s why we are dedicated to the development of our employees who work collectively to achieve our goals.
What Are We Doing in Richmond, CA?
We process high-quality allografts and human tissue for transplantation. These allografts are used in medical and surgical procedures to help physicians and their patients address various medical conditions.
Process Engineering at Aziyo
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, designing experiments to test the validity of the identified relationships, and to define how changes will be implemented. The Manager, Process Engineering will also author protocols and reports to verify or validate products, equipment, and/or processes 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.
What We Value:
- Leaders in Problem Solving – The Manager, Process Engineering problem-solves with a methodical approach and drives effective solutions for complex challenges through their leadership
- A Sense of Purpose – We value the Gift of tissue donation, and our success is attributed to our team’s work with these donations to improve patient outcomes globally and be part of something bigger than themselves
- Thirst for Knowledge and Development – The Manager, Process Engineering is dedicated to fostering this high-performance team so they can achieve outstanding results and contribute to the overall success of the organization
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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 and impact to key stakeholders. Drive implementation with planning and execution of identified process change deliverables.
- Define validation strategies incorporating project goals and compliance requirements.
- Act as subject matter expert on the design, development, and implementation of new equipment, new/improved processes, packaging, and technology transfers.
- 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 including sterilization validation, shelf-life studies, and microbial reduction strategies
- Facilitate the transfer of projects from Research and Development to routine production.
- Manage and direct activities of engineering team to align with team, site, and corporate objectives. Mentor engineer(s) to develop 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 eight 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.
Salary Range: $130,000 – $160,000 annually
Apply Now.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.
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