Responsibilities
- Design, prepare, and revise Electronic Batch Records (EBR).
- Support end users with EBR execution and usage.
- Manage EBR design/configuration changes, process reviews, and alignment with continuity-plan documentation.
- Initiate and own change controls for documents and equipment; ensure timely closure and implementation.
- Participate in process mapping; engage SMEs, leads, and operators to ensure critical parameters are captured.
- Serve as sustainment point of contact for electronic batch record manufacturing issues; escalate issues to SMEs/support.
- Execute functional verification protocols for MES/recipe design and baseline configuration.
- Support continuous improvement and applicable batch record changes.
- Follow up on BT tickets and ensure resolution of EBR issues.
- Ensure activities comply with procedures; identify deviations/exceptions and escalate appropriately.
- Adhere to safety procedure and GMP/GDP practices.
- Reassess/participate in agile change environment to drive continuous improvement; support projects/deployments.
- Participate in cross-functional teams to support, enhance, and upgrade AMPS.
- Assist with controlling/tracking periodic EBR procedure updates and manage emergency changes.
- Attend scheduled training and provide cross-training across AMPS areas.
Qualifications/Requirements
- Bachelorโs (0+ years) OR Associateโs (4 years) OR High school diploma (6 years) in relevant field.
- Pharmaceutical experience.
- Certifications: M1, Yellow Belt and/or Pfizer Human Performance methodology.
- Computer skills: HTML, Java, or object-oriented programming.
- Focused in systems analyst/data management.
- EBR/MES build experience.
- Experience working in Quality Tracking Systems.
Application
- Authorize to work in the U.S. (visa sponsorship not available for this role).