CSV Lead (Pharma)

Location: Hybrid in Prague, Czechia

Company

IT consultancy delivering software, AI, ML, BI, web, automation, and systems integration solutions for startups, mid-sized companies, and large corporations across regulated and industrial sectors.

What you will do

• Support CSV compliance for capital and strategic projects in a regulated pharmaceutical manufacturing environment.
• Develop, review, and approve validation lifecycle documentation.
• Guide SDLC, CSA, risk-based validation, qualification, and change control activities.
• Support validation and qualification of computerized manufacturing and laboratory systems.
• Review compliance deliverables against GxP requirements and internal procedures.
• Collaborate 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.
• Knowledge of GxP, data integrity, FDA/EMA requirements, and pharmaceutical compliance standards.
• Experience supporting computerized manufacturing or laboratory systems.
• Exposure to DeltaV DCS, Rockwell or Siemens PLC systems, Process Historians, or Laboratory Automation Systems.
• Fluent English required.

Culture & Benefits

• Full-time role in a hybrid work environment.
• Work across pharmaceutical manufacturing, laboratory automation, quality, engineering, and IT functions.
• Engagements are delivered through fixed-price and time-and-materials models.