Sr. Recipe Author

Pfizer • Kalamazoo, MI

21h • Onsite

About The Position

The recipe author will become proficient with the standard functionality of MES (Manufacturing Execution System) PharmaSuite and work with production units to convert paper records to EBR (Electronic Batch Record). They will focus on directly authoring and configuring master batch record and templates, revisions, validation and change controls of EBR 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.

Requirements

• 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.
• Proficiency in Microsoft office suite products (Word, Excel, Power point)
• SharePoint
• Effective oral and written communications skills
• Ability to perform mathematical calculations
• Ability to perform complex data analysis
• Permanent work authorization in the United States.

Nice To Haves

• Pharmaceutical experience
• M1, Yellow Belt and/or Pfizer Human Performance methodology certifications
• EBR Recipe Design and Authoring
• PharmaSuite
• AMPS (MES)
• HTML, Java, or object oriented programming
• Systems Analyst/Data Management focus
• Experience working in Quality Tracking Systems

Responsibilities

• Manage Electronic Batch Record (EBR) 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 EBR 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 escalate 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 EBR Issues.
• Ensure all the performed activities comply with respective area procedures.
• Identify deviations/exceptions and escalate 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 EBR 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 EBR procedure updates, periodic review of EBR 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 EBR training for new hires to the EBR recipe authoring team.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees