Pharma Manufacturing Process Analyst / Manufacturing Systems Specialis

Job Title:

Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist

Job Summary:

Manufacturing Systems Analyst

Key Responsibilities:

• Act as a functional SME for

  pharma manufacturing processes

  , providing process insights to support system operations and investigations.
• Review and analyze

  audit trail data

  generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles.
• Perform periodic review of

  alerts

  ,

  alarms

  , and

  exception logs

  as part of routine monitoring and deviation investigations.
• Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems.
• Support the digitization and continuous improvement initiatives in manufacturing areas.
• Participate in system validations, including URS development, system configuration reviews, and functional testing.
• Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring.
• Train end-users on manufacturing systems functionalities and regulatory requirements.

Required Skills and Qualifications:

• Strong understanding of

  pharma manufacturing processes

  (Batch Processing, Equipment Usage, Environmental Monitoring, etc.).
• Hands-on experience working with

  Pharma Manufacturing Systems

  (MES, DCS, SCADA, Historian platforms).
• Good knowledge of

  audit trail review

  and interpretation of manufacturing system logs.
• Understanding of

  alerts

  ,

  alarms

  , and deviation data as part of electronic record review.
• Familiarity with

  data integrity guidelines

  (21 CFR Part 11, EU Annex 11, WHO TRS).
• Experience in handling system compliance documentation (SOPs, URS, validation reports).
• Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders.

Preferred Qualifications:

• Knowledge of

  GAMP 5

  , CSV principles, and pharma regulatory requirements.
• Experience in data review from systems like

  Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms

  .
• Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.