Flex: Process Engineering Tech

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.

Look no further, we are hiring for a motivated, talented, and passionate Aseptic Process Engineer to join our St. The Aseptic Process 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 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.
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 (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).
Bachelor's degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science)
1+ years of experience in manufacturing, engineering, or quality.
Previous aseptic manufacturing experience preferred.
Six-Sigma training and project management experience is preferred.
Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
Demonstrated ability to contribute to and lead project teams.
Must be able to apply solid reasoning skills to an investigation and to project planning.
Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities.
Strong commitment to product quality and continuous improvement, with working knowledge of RFT principles.
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. 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.