Senior QA Expert CVS

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Competitive hourly rate

Zusammenfassung

Lonza in Stein, Switzerland is seeking a Senior QA Expert CSV to lead quality oversight across major CAPEX projects, ensuring MES/Automation systems meet GxP and regulatory requirements.

You will review validation lifecycle docs (FRS, IQ, OQ, PQ), manage MODA integration deliverables, Change Controls, Deviations, and collaborate across Automation, IT, Manufacturing and Engineering to keep systems compliant. Excellent English; German a plus. Site-based role with competitive compensation.

Qualifikationen

• Proven experience in Computerized Systems Validation (CSV) in biopharma.
• Strong knowledge of GAMP 5 and data integrity.
• Experience reviewing FRS, IQ/OQ/PQ documents.
• Excellent written and verbal communication.

Aufgaben

• Serve as the QA authority ensuring CSV meets GxP across major CAPEX projects.
• Perform QA review and approval of validation lifecycle documentation (FRS, IQ, OQ, PQ).
• Oversee and approve MODA integration deliverables and Automation Change Controls (ACCs).
• Assess and approve Change Controls, Deviations, and Incident Reports relating to automated systems and data integrity.
• Collaborate closely with cross‑functional teams across Automation, IT, Manufacturing, and Engineering to maintain systems in a compliant state.
• Provide expert CSV and data integrity guidance to project leads and operational partners throughout the project lifecycle.
• Support continuous improvement of validation standards and compliance frameworks within the site.

Kenntnisse

CSV expertise

GxP compliance

Validation oversight

Stakeholder collaboration

Ausbildung

Bachelor's or Master's in Engineering, Computer Science, Life Sciences or related field

Jobbeschreibung

Are you ready to play a critical role in ensuring software and computerized systems meet the highest compliance standards in pharmaceutical manufacturing? As a Senior QA Expert CSV, you will join our team in Stein to lead quality oversight across major CAPEX projects, directly contributing to the flawless execution of systems that deliver life-changing therapies.

Fully site‑based roles

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Competitive hourly rate / compensation package.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Serve as the QA authority ensuring computerized systems (MES, automation) meet GxP, GAMP, and regulatory requirements across major CAPEX projects (Dolphin, ADC, Kraken).
• Perform QA review and approval of validation lifecycle documentation, including Functional Requirement Specifications (FRS), IQ, OQ, and PQ protocols and reports.
• Oversee and approve MODA (MES) integration deliverables and Automation Change Controls (ACCs).
• Assess, manage, and approve Change Controls, Deviations, and Incident Reports relating to automated systems and data integrity.
• Collaborate closely with cross‑functional teams across Automation, IT, Manufacturing, and Engineering to maintain systems in a compliant state.
• Provide expert CSV and data integrity guidance to project leads and operational partners throughout the project lifecycle.
• Support continuous improvement of validation standards and compliance frameworks within the site.

What we are looking for:

• Proven experience in Computerized Systems Validation (CSV) within a GxP regulated biopharmaceutical environment.
• In‑depth understanding of Good Automated Manufacturing Practice (GAMP 5) guidelines and data integrity standards.
• Strong hands‑on background reviewing and approving validation documentation for Manufacturing Execution Systems (MES, ideally MODA).
• Practical expertise with Automation Change Control (ACC) management and deviation investigations.
• Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or a related discipline (or equivalent practical experience).
• Excellent communication and stakeholder management skills to collaborate across technical and operational teams.
• Professional fluency in English; proficiency in German is a distinct advantage.

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.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.