Changes to MBRs and updates to SDLC documentation (40%)
Leads the assessment of as-is processes and creation of to-be process (20%)
Resolution of L1 support escalations related to MBR use/entry
Escalation of support issues to MES Tech. Analyst & Global MES Team
Training of Manufacturing end users
Leading or supporting regulatory inspections of its subjects
Process Owner and/or Process Owner Backup of the system
Gathers and documents MES requirements
Owns the overall design and build of the electronic manufacturing batch records and associated process flows.
Ensures MBR designs include appropriate integrations and data flows between MES and other IT systems and shop floor equipment
Qualifications:
Hybrid role - 40% remote average, exact time will depend upon country minimum requirements; in office will always be in the jura region (first 3 months full office for team’s integration)
On call support on nights and weekends, approximately 1 week every 2 months, on a rotation with a team of 10 others
GMP knowledge
2 Years of PAS-X experience needed, a specific version of PAS-X experience not needed
Werum PAS-X and/or Siemens Simatic IT eBR process flow and electronic MBR building
CSV System Validation and MBR Verification experience