Sr. Recipe Author

What You Will Achieve

The recipe author will become proficient with the standard functionality of MES (Manufacturing Execution System) Pharma Suite and work with production units to convert paper records to E  (Electronic Batch Record). They will focus on directly authoring and configuring master batch record and templates, revisions, validation and change controls of E  Recipes at the Kalamazoo Manufacturing Site. The recipe author will have knowledge of SAP Functions including BOM, PV and IDOC management to assist in troubleshooting issues.

The recipe author will define and analyze business requirements through meeting with production units and develop detailed designs to meet those requirements. They will direct the coordination of standard work practices assuring alignment of supporting systems and reports. They will provide training to production units, troubleshooting, as well as ongoing data management for production units. In this role it is critical to be on-site engaging with operations on a regular basis to ensure understanding of processes and gathering critical parameters as well as supporting hypercare for go-live activities.

The recipe author will need to have a proactive approach in managing their time and engaging the production units.

• Responsibilities can include but not limited to:
  Manage Electronic Batch Record (E ) design and configuration changes, change control, updates, process reviews and alignment with associated documentation used to the lifecycle procedure.
• Facilitate, lead and participate in process mapping of business processes.
• Engagement of SME’s, Leads and Operators to ensure critical parameters are being captured.
• Support end users on E  execution and usage through training super users (as applicable). Be the first point of contact for electronic batch record manufacturing issues as part of sustainment team and elevate to leadership as needed.
• Background in automation integration requirements and systems to be able to support Edge Gateway, OPC Tunnelor and other automation capabilities integrated with MES.
• Having thorough knowledge of MES, recipe design, baseline configuration, writing and executing functional verification reports. Handling of Shop floor troubleshooting in SAP - AMPS interface for Electronic Batch Records.
• Management of IDOCs
• BT ticket follow ups and ensuring its resolution with E  Issues.
• Ensure all the performed activities comply with respective area procedures.
• Identify deviations/exceptions and elevate to leadership by appropriate procedures.
• Adherence to safety procedure, GMP and 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.
• Technical document writing for procedures, jobaids and functional verification protocols creation and execution.
• Assist in the work required to train, execute, track and reporting duties for other colleagues of the E  team.

• Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity
• To participate in internal & external (regulatory & non-Regulatory) audits.
• Assist Manager in tracking E  procedure updates, periodic review of E  procedures and emergency changes as required.

• To attend the training of all applicable procedures as per schedule.
• Colleague will be responsible for cross training to be able to support all AMPS areas being deployed or sustained.
• To develop and update content for AMPS E  training for new hires to the E  recipe authoring team.

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Computer
  
  Skills:
  
  SharePoint, Proficiency in Microsoft office suite products (Word, Excel, Power point)
• Language
  
  Skills:
  
  Effective oral and written communications skills

• Pharmaceutical experience
• Certifications:
  
  M1, Yellow Belt and/or Pfizer Human Performance methodology.
• Computer
  
  Skills:
  
  E  Recipe Design and Authoring, Pharma Suite, AMPS (MES), HTML, Java, or object oriented programming.
• Focused in Systems Analyst/Data Management.
• Experience working in Quality Tracking Systems.

• Ability to perform mathematical calculations and ability to perform complex data analysis

• Occasional travel may be required.
• In this role it is required to be onsite 5 days a week

The annual base salary for this position ranges from $82,700.00 to $. In addition, this position is eligible for participation in Pfizer's Global…