Senior Manufacturing Engineer

10 hours ago

St Louis MO USA, United States Kindeva Drug Delivery Full time
Job Title: Senior Manufacturing Engineer

Kindeva Drug Delivery is a leading global contract developer and manufacturer (CDMO) with expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world.

Job Summary:

The Senior 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.

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).
Requirements:
  • 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.
Experience:
  • 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.

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