Responsibilities
Author and configure Electronic Batch Record (EBR) recipes in PharmaSuite/MES, including master batch records/templates, revisions, validation, and change control.
Convert paper batch records to EBR; manage EBR design/configuration changes, updates, and alignment with lifecycle documentation.
Lead/process map business processes; engage SMEs/leads/operators to capture critical parameters.
Support end users with EBR execution and usage; act as first point of contact for manufacturing issues (sustainment/hypercare) and escalated as needed.
Support troubleshooting using MES knowledge and SAP (BOM, PV, IDOC management; SAP-AMPS interface); manage IDOCs; follow up on BT tickets.
Support automation integration capabilities (e.g., Edge Gateway, OPC Tunneler) and cross-functional AMPS support/upgrades.
Write technical documentation (procedures, job aids, functional verification protocols); assist training and tracking/reporting for EBR team.
Ensure compliance with cGMP/safety/GDP; participate in audits; identify deviations/exceptions and escalated.
Qualifications
Bachelor's (2+ years) OR Master's (0+ years) OR Associate's (6 years) OR High school (8 years) in relevant field.
SharePoint; Microsoft Office (Word/Excel/PowerPoint); strong oral/written communication.
Preferred
Pharmaceutical experience; M1, Yellow Belt and/or Human Performance certification.
EBR recipe design/authoring; PharmaSuite; AMPS (MES); HTML/Java/object-oriented programming; systems analyst/data management.
Experience in Quality Tracking Systems.
Benefits (as stated)
401(k) with matching and retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision.
Work schedule/location
On-site 5 days/week at Kalamazoo site.
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Scorpion Therapeutics is hiring: Sr. Recipe Author in Lansing
Scorpion Therapeutics · Lansing, MI, USA ·
- Job type:
- Full Time