Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.

• Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.

• Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

• Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.

• Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.

• Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.

• Experience reviewing and approving validation documentation and compliance deliverables.

• Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.

• Exposure to one or more manufacturing automation platforms including:

• DeltaV DCS
• PLC systems (Rockwell and/or Siemens)
• Process Historians
• Laboratory Automation Systems

• Experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.

• Understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms.

‍