MSAT Validation Expert – 7035 ADA

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 90.000 - 120.000; Teilzeit

Zusammenfassung

Lonza in Visp, Valais, Switzerland, is seeking an MSAT Validation Expert for a 9-month contract. You will support process and cleaning validation activities in our large-scale mammalian facility, ensuring quality and regulatory compliance.

The role requires a Master’s or PhD in biotech or life sciences, strong experience in process validation in a cGMP biopharma setting, and fluency in English (German a plus).

Qualifikationen

• Master’s or PhD in biotechnology, life sciences, or related field.
• Experience in process validation (and cleaning validation) in a cGMP biopharma setting.
• Proven ability to manage complex MSAT/Quality projects.
• Experience with regulatory interactions (Swissmedic, FDA, etc.).
• Fluent in English; German is a plus.

Aufgaben

• Develop validation strategies for process or cleaning in Visp Mammalian facility.
• Prepare/author validation protocols and reports per SOPs and regulations.
• Review and approve process/cleaning documents.
• Support PQ studies and protocol/report authoring.
• Represent Lonza in customer-facing meetings.
• Support SOP development to meet regulatory requirements.
• Assist during inspections by healthcare authorities and audits.

Kenntnisse

Process validation

MSAT

Regulatory experience

Technical writing

Stakeholder management

Project management

Ausbildung

Master's or PhD in biotechnology or life sciences

Jobbeschreibung

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a MSAT Validation Expert for a 9 months contract role based in the Valais area, Switzerland.

As part of the MSAT (Manufacturing Science & Technology) Validation team of our client's Large-Scale Mammalian facility in Visp, we are looking for a Validation Expert. In this role, you will be supporting the process and cleaning validation activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance.

Main Responsibilities:

• Support the development of validation strategies (process or cleaning, as defined) for the assigned projects in the Mammalian Large Scale facility in Visp.
• Prepare/author validation protocols and reports (for process or cleaning, as defined) according to 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.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• 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.