CQV Engineer – SPOC Utilities & HVAC 80-100% (m/f/d)
Core
Subject matter expert and primary point of contact for the qualification and validation of Utilities and HVAC systems throughout their lifecycle.
Role type
CQV Engineer (Utilities & HVAC)
Builds
Compliant, reliable, and efficient operation of pharmaceutical utilities and HVAC systems
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
HVAC systems knowledge, pharmaceutical utilities knowledge, GMP/GxP requirements, qualification planning, lifecycle management, deviation/investigation management, cross-functional collaboration
Preferred skills
German language knowledge
Technologies
HVAC systems, pharmaceutical utilities
Responsibilities
Lead planning, coordination, execution, and maintenance of qualifications and requalifications; Assess qualification impacts from installations, modifications, and changes; Prepare and maintain CQV, Engineering, and GMP documentation; Manage and support TCRs, deviations, investigations, and CAPAs; Partner with cross-functional stakeholders to deliver compliant solutions; Support audits, inspections, and decommissioning activities.
Seniority
Mid-Senior, hands-on IC
