Senior CSV / CQV Project Lead - Sweden

Advanced Manufacturing Tech Solutions (AMTSOL)
www.amtsol.com

A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

Role: Senior CSV / CQV Project Lead - Sweden

Industry: Pharmaceutical / Life Sciences
Start: ASAP
Full time : Onsite in Sweden
Project Phase: DeltaV Upgrade – (OQ)

Role Overview

This role is focused on advising, guiding, and stabilizing CQV execution, ensuring the project can progress through OQ and into commissioning readiness. The successful candidate will work closely with site teams, automation, engineering, and quality to bring proven DeltaV CQV experience and best-practice execution to the project.

Onsite presence is preferred to maximize impact, though a hybrid model may be considered for the right candidate. Immediate availability is highly desirable.

Key Responsibilities

• Provide senior leadership and hands-on guidance for CSV / CQV activities during the OQ phase
• Review current validation status, execution approach, and documentation
• Advise and support the existing CQV team to improve execution quality and pace
• Lead and guide DeltaV OQ planning, execution, deviation handling, and closure
• Identify critical risks, gaps, and recovery actions impacting project timelines
• Support commissioning readiness and transition from OQ to operational handover
• Act as a trusted technical advisor to site leadership and project stakeholders
• Ensure compliance with GxP, GAMP 5, and site validation standards
• Interface effectively with Automation, Engineering, QA, and Operations teams

Qualifications & Experience

• 15+ years experience in CSV / CQV within regulated pharmaceutical or biotech environments
• Proven experience leading DeltaV CQV activities, particularly OQ and commissioning readiness
• Strong understanding of DeltaV systems, automation lifecycle, and GMP validation requirements
• Demonstrated experience supporting challenged or recovery-phase projects
• Ability to work effectively in high-pressure, fast-moving project environments
• Hands-on, delivery-focused mindset rather than purely governance or oversight