CSV Lead (Pharmaceutical Compliance)

Location: Hybrid in Prague, Czechia

Company

hirify.global is an IT consultancy delivering software solutions across AI, ML, BI, web, automation, and regulated industry projects.

What you will do

• Support CSV compliance for capital and strategic projects in regulated pharmaceutical manufacturing.
• Develop, review, and approve validation lifecycle documentation.
• Provide guidance on SDLC, CSA, risk-based validation, qualification, and change control.
• Support validation and qualification activities for manufacturing and laboratory systems.
• Review compliance deliverables against GxP requirements and internal procedures.
• Coordinate with project, IT, engineering, quality, and manufacturing stakeholders.

Requirements

• Hands-on Computer System Validation experience in a GMP-regulated pharmaceutical or manufacturing environment.
• Experience with Validation Lifecycle, CSA, SDLC, IQ/OQ/PQ, Change Control, CAPA, and Risk Management.
• Experience reviewing and approving validation documentation.
• Knowledge of GxP, Data Integrity, and FDA/EMA requirements.
• Experience with computerized manufacturing or laboratory systems and exposure to DeltaV DCS, Rockwell or Siemens PLC systems, Process Historians, or Laboratory Automation Systems.
• Fluent English required.

Culture & Benefits

• Full-time hybrid work arrangement in Prague.
• Work across pharmaceutical, manufacturing, IT, quality, and engineering functions.
• Projects are delivered through fixed-price and time-and-materials models.