MSAT Process Engineer

Aristo Group; Luzern; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Lonza seeks a Senior Validation Specialist for the Mammalian Large Scale facility in Visp to lead validation strategy development, protocol and report authoring, and regulatory-compliant activities.

You will review and approve process/cleaning documents, engage with stakeholders, manage multiple tasks, and serve as SME during inspections and audits, with a strong emphasis on accuracy and regulatory alignment.

Qualifikationen

• Working experience in process validation within a cGMP-regulated biopharmaceutical environment.
• Experience managing complex projects, ideally in MSAT or Quality.
• Ability to manage multiple tasks and meet deadlines.
• Understanding of upstream and downstream processes in mammalian manufacturing.
• Exposure to process development, scale-up, and/or manufacturing (mammalian cell culture).
• Experience engaging with regulatory agencies (Swissmedic, FDA, etc.).
• Fluency in English (written and spoken); German is an advantage.

Aufgaben

• Support the development of validation strategies (process or cleaning) for the assigned projects in the Mammalian Large Scale facility of Lonza Visp.
• Prepare/author validation protocols and reports according to Lonza procedures and regulatory requirements.
• Reviewing and approving process/cleaning related documents.
• Support stakeholders during the execution phase.
• Assess validation data against acceptance criteria and support investigations of deviations (and approve DR).
• Act as a Subject Matter Expert (SME) for non-conformity records and change requests (validation assessment and approval).
• Support PQ studies (protocol/report authoring) related to process validation.
• Represent Lonza in customer-facing meetings as requested.
• Assist in developing SOPs to meet industry standards and regulatory requirements.
• Act as validation SME during inspections by healthcare authorities and customer audits.

Kenntnisse

Excellent communication

Technical writing

Stakeholder management

Fluency in English

Multitasking

German language (advantage)

Ausbildung

Master's or PhD in biotechnology or life sciences

Jobbeschreibung

• Support the development of validation strategies (process or cleaning, as defined) for the assigned projects in the Mammalian Large Scale facility of Lonza Visp.
• Prepare/author validation protocols and reports (for process or cleaning, as defined) according to Lonza procedure and in compliance with regulatory.
• Reviewing and approving process/cleaning related documents.
• Support stakeholders, as requested, during the execution phase.
• Assess validation data against acceptance criteria and support investigations of deviations (and approve DR)
• Act as a Subject Matter Expert (SME) for non-conformity records and change requests (responsible for the validation assessment and approval).
• Support PQ studies (protocol/report authoring) related to process validation.
• Represent, as requested, Lonza in customer-facing meetings
• Assist, as requested, in developing programs and Standard Operative Procedures (SOP) to meet industry standards and regulatory requirements
• Act, as requested, as validation SME during inspections by healthcare authorities and customer audits.

Key requirements:

• Master's or PhD degree in biotechnology, life sciences, or related disciplines.
• Working experience in process validation (ideally as well in cleaning validation) within a cGMP-regulated biopharmaceutical environment.
• Proven experience in managing complex projects, ideally in MSAT or Quality.
• Ability to manage multiple tasks and meet deadlines effectively.
• Understanding of upstream and downstream processes (preferably in mammalian manufacturing).
• Exposure to process development, scale-up, and/or manufacturing (preferably mammalian cell culture).
• Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
• Excellent communication, technical writing, and stakeholder management skills.
• Fluency in English (written and spoken); German is an advantage.