Takeda

Global MES Delivery Specialist

Takeda

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $111,800 - $175,670 per year

Job Level

Mid-LevelSenior

Tech Stack

Go

About the role

  • Lead the Global delivery of the Takeda MES solution to the GMS manufacturing network within the U.S.
  • Direct small/medium size projects, demonstrate strong business knowledge, require limited direction, handle complex problems
  • Identify, analyze, propose, and document appropriate solutions for problems and issues that may impact operations
  • Communicate project status and escalate challenges in a timely manner within the team and across functions or teams
  • Establish and maintain relationships within the business or function
  • Deliver MES site project as per MES Project Delivery Model
  • Gather and document business requirements and specifications for medium/large size projects
  • Maintain MES site roadmap
  • Manage budget and financials for the site projects
  • Assist in the development of business benefits for MES deployments
  • Provide global oversight of MES project deployments across manufacturing network
  • Partner with electronic Master Batch Record (MBR) Leads to leverage IT tools and best practices for business analysis, template/library use, and MBR creation
  • Business analysis for process redesign and conversion from paper manufacturing processes to digital
  • Partner with vendor and MBR Leads to find alternate ways to use MES out of the box in order to limit customizations
  • Provide end user support on applications supported within the organization
  • Mentor/train junior team members
  • Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project
  • Identify and understand broader business impact
  • Determine solutions and escalate when appropriate
  • Use technical tools for problem resolution
  • Manage MES IT template for projects in partnership with the MES technical team
  • Work with process/product owners to establish process flow standards in MES
  • Identify out of the box functions to leverage
  • Oversee build out of process/product templates to be leveraged by multiple manufacturing lines and plants
  • Analyze needs for MES customizations versus process workarounds
  • Support and maintain the MES community of practice across the Takeda operating networks
  • Partner with MES vendors to establish project teams and move projects through lifecycle
  • Link plant level project teams to global level standards for MES Design/Build/Validate/Go Live

Requirements

  • Bachelor’s or Master’s degree and/or >5 years of experience in applying information systems solutions to business problems
  • Experience in systems testing, validation, problem resolution, and training
  • >5 years of experience in the biotechnology and/or pharmaceutical industry
  • Knowledge of plasma, biologics, and small molecule manufacturing is a plus
  • Experience with MES or Automation systems
  • Experience with Werum PAS-X & Siemens Simatic IT eBR is a plus
  • Familiarity with business process flow and/or entity relationship modeling
  • Knowledge of the systems development life cycle and technology infrastructure
  • Excellent communication (verbal/written/listening) skills
  • Ability to present technical concepts to non-technical personnel
  • Experience with GMP systems and change management process
  • Good analytical and problem-solving skills
  • Excellent organizational skills
  • Sense of urgency with strong follow-up skills
  • Must be able to work within a cross-functional and globally dispersed team setting
  • Willingness to travel (up to 25%)
Benefits
  • Eligible for short-term and/or long-term incentives
  • Eligible for medical, dental, vision insurance
  • 401(k) plan and company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per year
  • New hires are eligible to accrue up to 120 hours of paid vacation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
MESbusiness analysissystems testingvalidationproblem resolutiontrainingGMP systemschange managementprocess redesignentity relationship modeling
Soft skills
communicationanalytical skillsproblem-solvingorganizational skillssense of urgencyfollow-up skillscross-functional teamworkmentoringrelationship managementpresentation skills