CQV Engineer

Panda International; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Panda International is seeking an experienced QA Validation Specialist for a major GMP manufacturing expansion in Visp, Switzerland. You will oversee qualification and validation activities to ensure that equipment, facilities, and systems remain qualified and compliant throughout their lifecycle.

You will collaborate with Operations, Engineering, and Regulatory bodies, applying CQV principles including IQ, OQ and PQ, and manage change controls while reviewing GMP documentation and supporting

Qualifikationen

• Experience in GMP environments and QA validation.
• Proven ability to review and approve GMP documentation (SOPs, protocols, reports).
• Strong knowledge of IQ/OQ/PQ and validation lifecycle.
• Proactive, autonomous with excellent communication.

Aufgaben

• Provide QA oversight of validation/qualification activities for GMP equipment, facilities and systems.
• Ensure systems remain validated throughout their lifecycle.
• Perform and assess change controls related to qualification activities.
• Develop validation protocols based on approved plans where required.
• Review and approve GMP documentation including deviations and CAPAs.
• Support audits and regulatory inspections (EU GMP, US FDA).
• Collaborate with Operations, Engineering, Validation and project stakeholders.

Kenntnisse

QA Validation

Change Control

Documentation Review

Regulatory Compliance

Stakeholder Management

Ausbildung

Degree in Engineering

Biotechnology or Chemistry background

Tools

DMS

LIMS

Kneat

TrackWise

Jobbeschreibung

Project: Major Biologics Manufacturing Expansion

About the Role

We are looking for an experienced QA Validation Specialist to join a major GMP manufacturing expansion project in Visp, Switzerland.

Reporting to the Head of QA Validation & Qualifications, you will be part of a small, highly collaborative team working closely with Operations, Engineering, clients, and regulatory authorities.

The project involves the expansion of mammalian cell culture and biologics manufacturing capabilities, including advanced automation, complex process control, and large-scale GMP manufacturing operations.

You will provide QA oversight of qualification and validation activities, ensuring that GMP equipment, facilities, and systems are properly qualified, validated, documented, and maintained in a compliant state throughout their lifecycle.

Key Responsibilities

• Provide QA oversight of validation and qualification activities for GMP equipment, facilities, and systems.
• Ensure systems remain in a validated and qualified state throughout their lifecycle.
• Perform and assess change controls related to GMP equipment, facilities, systems, and associated validation activities.
• Develop validation protocols based on approved validation plans where required.
• Review and approve GMP documentation, including:
• SOPs
• Validation protocols
• Validation reports
• Deviations
• CAPAs
• Change controls
• Apply strong knowledge of CQV and validation principles, including IQ, OQ and PQ.
• Support qualification and validation activities involving:
• GMP manufacturing equipment
• Autoclaves
• Temperature mapping
• Controlled storage rooms and equipment
• Work with Quality Systems including DMS, LIMS, Kneat and TrackWise.
• Support audits and regulatory inspections, ensuring compliance with EU GMP and US FDA requirements.
• Collaborate closely with Operations, Engineering, Validation, and other project stakeholders.
• Contribute to continuous improvement initiatives and other QA activities as required.
• Plan and manage your own workload effectively and support activities assigned by the Validation Manager.

Requirements

• 2–6 years of experience in Validation / Qualification within a GMP-regulated environment.
• Experience in pharmaceutical, biotechnology, or cell & gene therapy manufacturing.
• Strong understanding of:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation lifecycle
• Maintaining systems in a validated state
• Change Control
• GMP documentation review
• Proven experience reviewing and approving GMP documentation, including SOPs, protocols, reports, deviations, CAPAs, and change controls.
• Good knowledge of EU GMP and FDA regulations.
• Strong English communication skills; German is an advantage.
• A degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or another relevant scientific/technical discipline is preferred, but relevant professional experience can compensate for formal academic qualifications.

Personal Attributes

We are looking for someone who can hit the ground running and contribute effectively during a critical phase of a major manufacturing project.

You should be:

• Highly autonomous and proactive.
• Comfortable working in a fast-paced GMP environment.
• Able to quickly understand new processes, systems, and technical requirements.
• Strong in communication and stakeholder management.
• Comfortable working in a multicultural and highly collaborative environment.
• Detail-oriented with a strong quality and compliance mindset.

Why Join?

This is an excellent opportunity to join a high-profile biologics manufacturing expansion in Visp and contribute to a critical stage of a major GMP project.

You will work alongside experienced professionals across QA, Engineering, Operations, and Validation, gaining valuable exposure to large-scale biologics manufacturing, CQV, advanced automation, and regulatory compliance.