Recipe Author

Use your expertise to convert paper records to Electronic Batch Records (EBR) within the MES PharmaSuite system. This role focuses on authoring, configuring, and maintaining master batch records, templates, revisions, validation, and change controls at the Kalamazoo Manufacturing Site.

About the Role

The EBR Recipe Author will define and analyze business requirements through collaboration with production units, develop detailed designs, and provide initial training during deployment. This position requires on-site engagement with operations to ensure process understanding and gather critical parameters, along with proactive time management and production unit engagement.

Responsibilities

• Design, prepare, and revise Electronic Batch Records (EBR).
• Support end users on EBR execution and usage.
• Manage EBR design and configuration changes, process reviews, and alignment with associated documentation for continuity planning.
• Initiate and own change controls related to documents and equipment, ensuring timely closure and implementation.
• Participate in process mapping of business processes.
• Engage with Subject Matter Experts (SMEs), Leads, and Operators to capture critical parameters.
• Serve as the point of contact for electronic batch record manufacturing issues as part of the sustainment team.
• Escalate electronic manufacturing execution issues to subject matter experts or supporting teams.
• Maintain thorough knowledge of Manufacturing Execution System (MES), recipe design, baseline configuration, and functional verification protocols.
• Act as part of the sustainment team to support continuous improvement and batch record changes.
• Follow up on BT tickets and ensure resolution of EBR issues.
• Ensure all activities comply with respective procedures and identify/escalate deviations or exceptions.
• Adhere to safety procedures, GMP, and GDP practices.
• Reassess and participate in an agile change environment to enhance processes, eliminate non-value-added activities, and drive continuous improvement.
• Participate in cross-functional teams to support, enhance, and upgrade AMPS.
• Ensure compliance with cGMP, safety, and Pfizer integrity principles at all stages of activity.
• Assist the Manager in controlling, tracking, and updating EBR procedures, including managing emergency changes.
• Attend training for all applicable procedures as scheduled.
• Responsible for cross-training to support all AMPS areas being deployed or sustained.

Requirements

• Bachelor’s degree with 0+ years of experience; OR an associate’s degree with 4 years of experience; OR a high school diploma (or equivalent) with 6 years of relevant experience.
• Pharmaceutical experience.
• Certifications: M1, Yellow Belt, and/or Pfizer Human Performance methodology.
• Computer Skills: Proficiency in HTML, Java, or object-oriented programming, with a focus on Systems Analyst/Data Management.
• EBR/MES build experience.
• Experience working in Quality Tracking Systems.
• Ability to perform mathematical calculations and complex data analysis.

Schedule

This role requires on-site presence 5 days a week. Occasional travel may be required.

Pay

The annual base salary for this position ranges from $68,600.00 to $114,300.00. This position is also eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and eligibility.