Aseptic Process Engineer

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The aseptic manufacturing engineer is a key technical role responsible for ensuring consistent high performance of aseptic manufacturing processing areas. The role requires specialized aseptic manufacturing and compliance experience. The incumbent will provide focused technical ownership over manufacturing processes while driving quality, the implementation of best practices, and continuous improvement. As the technical lead on aseptic compliance, the aseptic manufacturing engineer partners with production, quality, and compliance colleagues to identify and implement innovative solutions.

This role is required to be on-site at our Brentwood facility and relocation assistance is available for qualified candidates who are not local to the St. Louis area.

Role Responsibilities

• Observe, analyze, and identify aseptic process improvement opportunities on the manufacturing floor.
• Effectively manage and coordinate aseptic manufacturing projects and other functions at the site in support of technical projects.
• Partner with Sterile Product Manufacturing principles, Quality Assurance, and other internal experts to develop quality investigations, assign root cause, and identify/implement CAPA solutions.
• Work with Quality Operations and Regulatory Affairs to ensure regulatory filings are completed on time and to the appropriate standard.
• Champion process change proposals/requests as relates to Technical Support operations.
• Act as internal technical and compliance training resource for both SPM management and SPM production floor team.
• Ensure work activities are conducted in strict accordance with safety guidelines and processing standards, such as FDA's current good manufacturing practices and standard operating procedures.
• Aseptic qualifications are completed and maintained.

Basic Qualifications

• 2 + years of experience in pharmaceutical manufacturing and a background in manufacturing or quality.

Preferred Qualifications

• Bachelor's degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science).
• Previous aseptic manufacturing experience.
• Six-Sigma training and project management experience.

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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