CQV Lead – Fill & Finish

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.

Are you passionate about CQV and interested in GxP environments?

Join a team where your skills will make a real impact on patients' lives.

As CQV Lead – Fill & Finish
, you’ll lead Commissioning, Qualification, and Validation (CQV) activities for sterile manufacturing equipment and supporting utilities in cutting‑edge Fill & Finish environments — including isolators, lyophilizers, autoclaves, and high‑precision dosing systems.

You’ll work at the interface of engineering, compliance, and operations to ensure timely, GMP‑compliant project execution in a high‑quality, safety‑conscious, and people‑oriented setting.

• Lead CQV Execution
  :
  Oversee and coordinate commissioning and qualification for Liquid and Lyophilized Vial Filling lines, including isolators, lyophilizers, and sterilization equipment.
• Strategic Planning
  :
  Define, maintain, and adjust CQV plans and schedules in alignment with project milestones and client expectations.
• Interface Management
  :
  Act as the link between vendors, automation, operations, and engineering teams during FAT, SAT, IQ, and OQ phases.
• Technical Documentation
  :
  Review and support the development and execution of test protocols (FRA, DQ, IQ, OQ) — Experience with digital tools like Kneat is a strong plus.
• Compliance Assurance
  :
  Ensure activities adhere to cGMP, EU Annex 15, and client‑specific validation standards.
• Team Leadership
  :
  Coordinate a cross‑functional CQV team, mentor junior engineers, and foster a solution‑oriented mindset.
• Filling & Stoppering
  :
  Piston and peristaltic pump systems
• Isolators
  :
  Grade A (ISO
  5), glove integrity testers, H2O2 decontamination
• Lyophilizers
  :
  With dedicated isolators and mass spectrometers
• Support Systems
  :
  Autoclaves, stopper treatment stations, HVAC, automation
• 10+ years of experience in CQV roles within sterile Fill & Finish pharma or biotech operations
• Degree in Mechanical, Chemical, or Life Sciences Engineering (or equivalent practical experience)
• Proven track record with lyophilized and liquid fill/finish processes
• Deep understanding of cGMPs, validation principles, and cleanroom environments
• Experience in managing vendors, third‑party contractors, and cross‑functional teams
• Fluent in English
  ; German is a strong plus
• Human‑sized company with great colleagues from a large diversity of cultural and professional backgrounds
• Open and transparent culture
  :
  We foster honest communication, active listening, and continuous feedback.
• Work as a TEAM where every member is valued and appreciated
• Real impact on projects and clients
  :
  You’re at the heart of the action — your ideas influence strategy and outcomes, within an international and multicultural environment.
• Direct access to leadership and strong internal visibility
  : A flat structure with no unnecessary layers — your voice truly matters.
• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits.