Job Details

  • Title: EBR Recipe Design Author
  • Code: RCI-24858-1
  • Location: Kalamazoo, MI 49001
  • Posted Date: 05/13/2022
  • Duration: 12 Months
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  Job Description

Position Description



  • The EBR Recipe Design Author will focus on the design, preparation, revision, validation and change controls of EBR Recipes at the Kalamazoo Manufacturing Site.
  • They will have thorough knowledge of MES.
  • Assist and Execute supporting SAP Functions BOM, PV and IDOC management.
  • The recipe author will coordinate supporting functional departments for smooth production activities and ensure all performed activities comply with respective procedures.
  • They will direct the coordination of standard work practices assuring alignment of supporting systems and reports.
  • Providing training, audit file monitoring and troubleshooting, as well as on going data management.
  • As a Business Systems Professional, they are responsible for SCO SOP management for their area.
  • They will reassess the business processes at intervals to eliminate non-value-added activities and drive continuous improvement.
  • In addition will also support other Business Operating Systems owned by the Supply Chain Business Systems Team and various interfaces as needed and required.



Responsibilities can include but not limited to:


  • Design, preparation/revision of Electronic Batch Records (EBR).
  • Supporting end users on EBR execution/usage.
  • Manage EBR design and configuration changes, Change Control, Updates, Process Reviews and alignment with associated documentation used to the continuity plan.
  • Facilitate lead and participate in process mapping of business processes
  • Be the first point of contact for electronic batch record manufacturing issues.
  • Escalation of Electronic manufacturing execution issues to Subject matter expert or supporting team.
  • Having thorough knowledge of manufacturing execution system (MES), recipe design, baseline configuration, writing and executing functional verification reports.
  • Conducting trainings to executing personnel on EBR system when upgrades are made to the system or recipes.
  • Handling of Shop floor troubleshooting in SAP- AMPS interface for Electronic Batch Records.
  • Tracking of AMPS recipes revision as per revised/new batch records.
  • Handling of SAP/EBR related issue and shop floor support.
  • Management of IDOCs
  • BT ticket follow ups and ensuring its resolution with EBR Issues.
  • Coordinate supporting functional departments for smooth operation of production activities when reviewing and developing recipes.
  • Ensure all the performed activities comply with respective procedures.
  • Initiating change controls related to documents, equipment. Ensuring their closure and implementation of changes within specific time.
  • Identify deviations/exceptions and escalate to manger by appropriate procedures.
  • -Adherence to safety procedure/GMP & GDP practices.
  • Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continuous improvement including supporting projects and deployments.
  • Participate in cross functional teams to support, enhance, and upgrade AMPS
  • Lead or Participate in Projects/Deployments
  • Impact assessment
  • Master data clean-up
  • Recipe Design and Authoring
  • Testing
  • SOP Updates
  • BCD Updates
  • Functional Verification Testing
  • Writing and implementing protocols
  • Training
  • They can also assist in the work required to train, execute, track and reporting duties for other colleagues of the Business Systems Support team.

Quality Management and Compliance:

  • Ensure compliance of operations to cGMP, safety and Client integrity principles at all stages of activity
  • To participate in internal & external (regulatory & non-Regulatory) audits.
  • Assist Manager in controlling tracking and periodic EBR procedure updates and manages emergency changes appropriately.


  • To attend the training of all applicable procedures as per schedule.
  • Training the team on relevant procedures and getting trained on respective area of work.
  • To develop content for AMPS EBR training to new hires and refresher training as needed to end users.


Education: Bachelor's Degree

Computer Skills:

  • EBR Recipe Design and Authoring, Pharmasuite, AMPS (MES), SharePoint Proficiency in Microsoft office suite products (Word, Excel, Power point), QTS or Experience working in Quality Tracking Systems.

Language Skills:

  • Effective oral and written communications skills


  • Pharmaceutical experience
  • Certifications: M1, Yellow Belt and/or APICS
  • Computer Skills: HTML, Java, or object oriented programming
  • Focused in Systems Analyst/Data Management.