About Us

Portal Biotech has built the world’s only platform capable of sequencing full-length proteins at the single-molecule level. Using our nanopore technology, we read intact proteins of any size, capturing both sequence and post-translational modifications in a way no other system can. This opens up entirely new ways to understand protein biology, with applications across drug discovery, diagnostics, and biosecurity.
Our technology works and customers are engaging. We’re now focused on scaling, turning breakthrough science into products that deliver real biological insight as we move beyond Series A towards global product launch

About the role

We are seeking a Quality Engineer to support and oversee manufacturing quality activities within our pilot manufacturing operation. Based at our London site and working closely with both the manufacturing team and the wider Quality organisation, this is a primarily on-site role combining hands-on involvement with the development of robust quality systems.

You will be responsible for ensuring manufacturing activities are controlled, documented, and compliant with quality system requirements. This role will support the development of a structured and audit-ready manufacturing environment aligned to ISO 9001, with progression toward ISO 13485.

In the early phase, this role will include active participation in manufacturing activities on the production line, ensuring quality systems and controls are developed based on real operational conditions.

Tasks and responsibilities

• Review manufacturing records and support product release activities

• Ensure manufacturing processes are documented, controlled, and consistently followed

• Manage deviations, CAPA, and change control processes

• Lead and maintain risk management activities (e.g. FMEA, ISO 14971 aligned)

• Support design verification and validation activities, ensuring manufacturing considerations are captured

• Own and maintain the Master Validation Plan (MVP) for manufacturing

• Review and approve validation protocols and reports

• Ensure manufacturing activities generate appropriate documentation and traceability

• Maintain audit-ready records and support internal and external audits

• Work closely with the central Quality organisation to ensure alignment with company quality systems

• Support implementation and use of electronic quality management systems (eQMS) where applicable

• Participate in manufacturing activities during early pilot phases to ensure effective quality oversight and process alignment

Qualifications

• Degree in Engineering, Quality, Life Sciences, or a related discipline, or equivalent industrial experience

• Proven experience in quality roles within manufacturing or regulated environments

• Strong understanding of quality systems, including ISO 9001; exposure to ISO 13485 preferred

• Experience with deviation management, CAPA, and change control

• Track record in risk management methodologies (e.g. FMEA)

• Experience supporting validation activities

• Strong attention to detail and structured, methodical approach

• Ability to work cross-functionally and influence without direct authority

Desirable

• Proven experience in ISO 13485 and ISO 14971 environments

• Hands-on experience with electronic Quality Management Systems (eQMS)

• Background in computerised system validation or assurance

• Exposure to pilot or early-stage manufacturing environments

• Involvement in design validation activities within product development

• Supporting audits or regulatory inspections

This is a hands-on role within an early-stage manufacturing team, where you will help build and refine processes based on real operational experience. You will play a key part in establishing robust, scalable systems that will underpin future manufacturing capability.

We offer a competitive salary and benefits package. If you are passionate about building robust manufacturing systems and contributing to the delivery of innovative scientific technologies, we encourage you to apply!