Kindeva Drug Delivery
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 Sr. Manufacturing Engineer to join our St. Louis Missouri team!
The Sr. Manufacturing Engineer is a key technical role responsible for ensuring consistently high performance of manufacturing equipment and processes. The role requires strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. The incumbent will provide focused process ownership and technical expertise to ensure high quality and efficient sterile injectable products. As technical lead, the Sr. Manufacturing Engineer partners with supervision and production colleagues to identify and implement innovative solutions. Additional duties include project management, six sigma methods, and training coordination.
ROLE RESPONSIBILITIES:
Assigned technical lead and owner of SPM manufacturing equipment and process systems.
- Effectively manage and coordinate aseptic manufacturing technical processes and functions at the site in support of technical projects.
- Collaborate with and provide technical leadership to Sterile Product Manufacturing (SPM) principals, Quality Assurance (QA), Operational Excellence (OPEX), and other internal experts to develop quality investigations, assign root cause, and identify/implement CAPA solutions.
- Investigate process deviations that occur on manufacturing floor using structured Six Sigma-based methods.
- As an individual contributor, represent manufacturing on assigned to project teams to ensure completion of key projects initiatives.
- Act as internal technical training resource for both SPM Management and SPM production floor team.
- Provide support to 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.
- Provide support to manufacturing staff on the production floor to affect smooth scale-ups and technical transfers.
- Anticipate potential problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.
- Identify and implement cost savings initiatives, specifically quality and efficiency improvements.
- Maintain product and company reputation by complying with government regulations; and champions manufacturing safety initiatives.
- Lead technical improvement projects aimed at "zero defects", equipment reliability, and maximized utilization.
- 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).
Education:
- Bachelor's degree (or higher) in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a Science-related field.
- Knowledge of electro-mechanical principles and automated machine process control.
- Ability to clearly present technical information and effectively communicate within all levels of the organization.
- Demonstrated ability to contribute to and lead project teams.
- Clear thinker: simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely.
- 5-10 years' experience in pharmaceutical manufacturing and background in manufacturing or quality
- Previous aseptic manufacturing experience preferred.
- Technical Skills:
- 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.
- Demonstrated commitment to values-based leadership and achieving objectives in a manner that is consistent with Kindeva Leader Behaviors.
- Demonstrated ability to interact effectively with all levels of the organization.
- Strong oral and written communication skills required.
- Possess flexibility to respond to constantly changing conditions and priorities.
- Six-Sigma training and project management experience is preferred.
- Strong commitment to product quality, continuous improvement, and working knowledge of RFT principles.
California residents should review our Notice for California Employees and Applicants before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
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.
Other details
- Job Family Management I
- Job Function Management
- Pay Type Salary
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