Process Engineer

Process Engineer Kindeva Drug Delivery Careers - 2.1 St. Louis, MO Job Details Full-time 23 hours ago Qualifications Quality control corrective actions Biology Biochemistry Process optimization Engineering Safety standards in production Six Sigma methodology implementation Corrective and preventive actions (CAPA) Mid-level Microbiology Bachelor's degree in biology Manufacturing standard operating procedures Project management Bachelor's degree in engineering Performance Improvement (PI) Pharmacy Chemistry Regulatory submissions Quality assurance within manufacturing Root cause analysis Aseptic technique Bachelor's degree in microbiology Bachelor's degree in biochemistry 2 years Manufacturing company experience Process engineering Bachelor's degree in chemistry Regulatory compliance management FDA regulations Training delivery Full Job Description Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. Ready to work with purpose? Look no further, we are hiring for a motivated, talented, and passionate Aseptic Process Engineer to join our St. Louis Missouri team!

ROLE SUMMARY

The Process Engineer is a key technical role responsible for ensuring consistent high performance of manufacturing processing areas. 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 operations, the Aseptic Manufacturing Engineer partners with production, quality, and compliance colleagues to identify and implement innovative solutions. Additional duties include project management, six sigma methods, and training coordination.

ROLE RESPONSIBILITIES

Observe, analyze, and identify 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 (SPM) principals, Quality Assurance (QA), 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 (cGMPs) and Standard Operating Procedures (SOPs).

QUALIFICATIONS

Bachelor's degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science) 2+ years of experience in manufacturing or quality. Previous aseptic manufacturing experience preferred. Six-Sigma training and project management experience is preferred. California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer:

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. Do you see yourself as part of the Kindeva mission? Click Today!