Global MSAT Drug Product Qualification & Validation Lead

This position is located in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

For our successful and growing Drug Product focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Global MSAT DP Qualification & Validation Lead position.

What you will get :

An agile career and a dynamic work culture

An inclusive and ethical workplace

Compensation programs that recognize high performance

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.

Benefits in Stein : https : / / bit.ly / 42DlBDk

What you will do :

Lead global process control strategy for drug product manufacturing

Own global strategies for equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV)

Define and govern global SOPs, standards, templates, and tools aligned with regulations and best practice

Own qualification strategy for key unit operations : thawing, compounding, filling, lyophilization, and crimping

Guide Tech Transfer and local MSAT teams on validation strategies, scale‑up, and sampling plans

Review and approve validation documentation; analyze production data using appropriate statistical methods

Act as subject‑matter expert during health authority inspections on validation and CPV / OPV

What we are looking for :

Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field; or equivalent experience

Expertise in equipment qualification for aseptic drug product manufacturing

Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats

Proven experience with regulatory submissions and pre‑approval inspections

Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred

Knowledge of risk assessment, deviation management, change control, and root cause analysis

Excellent English communication, documentation, leadership, and cross‑functional collaboration skills

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.