C&Q Lead

Location: Basel area
Length: 6–12-Month
Workload: 100%

Start Date: ASAPWe are supporting a major CAPEX project in the Basel area and are looking for an experienced CQV Lead to strengthen the team. The project is entering its third qualification phase and is currently subject to audit scrutiny, making this role critical in ensuring compliance, quality, and on-time delivery. The role requires an experienced engineer with a strong background in commissioning and qualification to direct equipment qualification, ensure QA approvals, and secure compliance with project timelines.

Your Tasks: 

• Lead Commissioning & Qualification (C&Q) activities for large-scale equipment

• Direct and oversee IQ/OQ/PQ

• Ensure compliance and audit readiness during process qualification
  

• Drive QA approvals and liaise with Head of QA

• Troubleshoot and resolve technical qualification issues

• Align project deliverables with CAPEX timelines and escalate risks when deadlines are at risk

• Provide expertise and strategic direction across stakeholders

Your Profile:

• 7–10 years CQV experience in GMP pharma (focus on large-scale equipment)

• Engineering background with proven hands-on qualification/validation

• Track record leading teams in CAPEX projects (project lead or PM style)

• Experience working with or closely supporting QA functions

• Strong technical problem-solving and troubleshooting skills

• Strategic mindset with ability to coordinate across functions

• English; understanding German required

• Previous experience in international pharma/biotech environments advantageous