Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)

Lonza; Schweiz; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, seeks a Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d) to lead GMP deviation investigations on site. You will collaborate with Operations, QA, MSAT, QC and Engineering to ensure product quality and regulatory compliance in a high‑regulation biopharma environment.

Responsibilities include structured fact finding, root‑cause analysis, CAPA development, and drafting investigation records; you will support audits and inspections and help standardize

Qualifikationen

• Experience in GMP-regulated manufacturing environments.
• Experience leading or supporting deviation investigations and CAPA processes.
• Strong understanding of GMP requirements and quality systems.

Aufgaben

• Lead GMP deviation investigations for manufacturing and related activities.
• Conduct structured fact finding, event reconstruction, root cause analysis and impact assessments.
• Draft, review, and close deviation records with CAPA actions.
• Support internal audits, customer inspections, and regulatory inspections with investigation outcomes.

Jobbeschreibung

Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)

Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)

The actual location of this job is in Visp, Switzerland.

Join a dedicated team at the forefront of GMP manufacturing excellence, where you will lead critical deviation investigations that help ensure the quality, safety, and reliability of life-changing therapies. This is an exciting opportunity to apply scientific expertise, collaborate across multiple functions, and drive continuous improvement in a highly regulated biopharmaceutical environment.

This role is primarily based on site. 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.
• Compensation programs that recognize high performance.
• Opportunities to work with highly experienced cross-functional teams in a world-class biopharmaceutical manufacturing environment.
• Professional development through exposure to complex GMP investigations, inspection readiness activities, and continuous improvement initiatives.
• A variety of benefits dependent on role and location.
• Lead and author GMP deviation investigations for manufacturing, cleaning, qualification, and operational events within Module L.
• Conduct structured fact finding, event reconstruction, root cause analysis, impact assessments, recurrence evaluations, and product quality assessments in collaboration with process subject matter experts.
• Partner closely with Operations, QA, MSAT, QC, Engineering, Manufacturing Support, and other stakeholders to define effective corrective and preventive actions (CAPAs).
• Drive deviation records through drafting, review, comment resolution, approval, and closure, ensuring compliance with agreed priorities and timelines.
• Maintain investigation records that are complete, scientifically sound, traceable, inspection-ready, and compliant with GMP requirements and site procedures.
• Support internal audits, customer inspections, and regulatory authority inspections by presenting investigation outcomes, impact assessments, root cause rationale, and CAPA strategies.
• Contribute to deviation reduction initiatives, recurring issue analysis, workload tracking, and the continuous improvement and standardization of investigation practices across the team.

What we are looking for:

• Experience within biotechnology, biopharmaceutical, pharmaceutical, or GMP-regulated manufacturing environments.
• Demonstrated experience leading or supporting deviation investigations, root cause analysis, CAPA management, and quality system processes.
• Strong understanding of GMP requirements, manufacturing processes, cleaning validation, qualification activities, and quality risk management principles.
• Ability to analyze complex technical data, assess product and process impact, and develop scientifically justified conclusions.l
• Excellent stakeholder management and communication skills, with the ability to collaborate across Operations, QA, MSAT, QC, Engineering, and Manufacturing teams.
• Degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline, or equivalent experience gained in a relevant environment.
• Strong organizational skills with the ability to manage multiple priorities, drive timely execution, and maintain high-quality documentation standards.

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.