Process Excellence Engineer

7/6/22

Riverview, MI

1745

Process Excellence Engineer
Job requirements:

  • Adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies, and practices.
  • Identify and protect the original technical information as part of the company property.

Key responsibilities.

  • Accountability of end-to-end process engineering responsibility for the product/products for commercial or development projects
  • Preparing unplanned and planned deviations for responsible processes and forming the investigation team.
  • Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure.
  • Work with project and engineering teams to replace existing/modify or buy equipment’s for continuous improvement or capacity enhancement
  • Functions as the technical interface between Company and the Client focus on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries.
  • Requires solid understanding of the manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and complete understanding of production processes in the GMP environment.
  • Willingness to work flexible hours and shifts when there is a need.
  • Drive projects to improve the process performance of the site and improve Right First-Time performance (RFT)
  • Ensure delivery of business process improvement initiatives through the implementation of predetermined/agreed synergies.
  • Benchmark and transfer best practices and procedures across all from different sites to enable shared growth.
  • Drive ideation every year to optimize cost, productivity, and manage projects throughout the plant in all the departments.
  • Lead VSM on a timely basis across for critical products to optimize lead-time and reduce/mitigate Non-Value Added (NVA) activities.
  • Drive automation at Riverview Site with new systems and projects to reduce manual processes.
  • Identify improvement opportunities in processes- Lead projects to enhance Safety, Productivity, Quality, Cost, Delivery/Inventory of Riverview Site continuously
  • Support focused Site Improvement Teams & Daily Management Teams and showed improvements in chosen KPIs.
  • Support sites in preparing MIS report every month.
  • Use Lean and Six Sigma tools & methodology, ensure that the tools are used appropriately by team members, identify, and assist in removing barriers to projects.
  • Conduct Kaizen and KPI competition amongst the group, sharing OE best practices across various plants in the organization.
  • Facilitate Lean Six Sigma – White Belt, Yellow Belt, Green Belt, and ‘Lunch & Learn’ training Programs across locations to build a culture of continuous improvement.
  • Train teams in structured Problem-Solving techniques.
  • Ensure process data is being updated monthly; analyse manufacturing KPI performance for improvement and discussion with client. Coordinate the qualification of primary and secondary regulatory starting material suppliers for assigned projects.

EDUCATION/EXPERIENCE.

  • Bachelor’s Degree in Chemistry or Engineering or similar pharmaceutical discipline is required.
    • Master’s Degree or PhD preferred, in lieu of work experience.

At least 1-5 years of relevant work experience in the pharmaceutical industry. API preferred.

  • Demonstrated project management and technical leadership capabilities.
  • Confident management of internal and external stakeholder relationships.
  • Good written and oral communication skills.
  • Demonstrated teamwork skill and professionalism in all interactions.
  • Proven track record of successful technology transfer.
  • Working knowledge of process and desktop computers.

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