Black Belt - OQSIE

Looking for a Six Sigma Black Belt with experience improving aseptic manufacturing processes in the Life Sciences industry.  Leveraging the DMAIC framework, this professional will collaborate with client team members in the identification, planning, and implementation of improvement opportunities that help address critical business needs in th

Six Sigma Black Belt will handle and prevent critical Aseptic Manufacturing issues. The types of issues that may arise include equipment, methods, procedures, yields, stains, fixes, triaging problems that turn on a dime, and more.

SCOPE; ACTIVITIES, TASKS:

Process Engineers will perform the following activities:

·         Lead a group of SME’s to identify sources/causes for a specific device failure mode.

·         Set up a project scope, lead meetings, summarize meeting minutes, conduct follow up with SME’s and issue a final report.

·         Will utilize their Black Belt certification knowledge and job experience to handle critical manufacturing issues that are known, unknown and to prevent future issues from happening.

·         Will handle change control and utilize their FDA industry experience to maintain compliance.

·         Will utilize their Aseptic Manufacturing expertise to prevent and solve problems in an effort to minimize production down time.

·         Will drive multiple projects simultaneously through completion, to meet short implementation deadlines.

Process Engineers will:

·         Proactively identify problems that could stop/slow production in the future.

·         Reactively identify solutions to problems, track progress, drive projects through to completion and report real-time status to SPM management.

·         Handle multiple small and large projects at the same time, alone or with other team members and be able to solve and push through each project successfully, amidst to changing priorities.

·         Produce a measurable difference in preventing plant shut-down, based on assigned projects.

REQUIREMENTS:

·         Must be a Six Sigma Certified Black Belt

·         Will have experience in leading a group of SME’s to identify sources/causes for a specific device failure mode.

·         Will have experience in setting up a project scope, lead meetings, summarize meeting minutes, conduct follow up with SME’s and issue a final report.

·         Ideally will have a degree in or experience with process engineering.

e client’s aseptic manufacturing area.  

Minimum Qualifications:
•    Certified Six Sigma Black Belt (CSSBB) or Lean Six Sigma Master Black Belt (CSSMBB)
•    Experience leading improvement projects in an Aseptic Manufacturing environment (Clean & Prep, Formulation, Filling)
•    Strong Project Management skills