Manufacturing Engineer

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are now seeking two motivated Manufacturing Engineers to join the growing manufacturing team.

Position Overview

The manufacturing engineer is responsible for securing GMP compliance and technical readiness of the facility, equipment, process, and product. The incumbent will be required to work within grade D, C, and B cleanroom classified areas applying a high standard of good manufacturing practices (GMP) and good documentation practices (GDP) as outlined by annex 1.

The manufacturing engineer will be supporting the GMP (clinical and/or commercial) manufacturing of ATMP, cell products and will be required to display a continuous improvement mind set. The role includes cross-functional collaboration with other departments such as MSAT, QA, and Supply Chain.

The department will ensure compliance with Procella quality management systems, registered files, current regulatory requirements and quality criteria.

Position Responsibilities

- Support the daily activities in the GMP, cleanroom facility.

- Support cross-functional and external activities related to manufacturing.

- Produce clinical and/or commercial stem cells therapies in accordance with regulatory requirements.

- Execute GMP processes according to production schedules and instructions (e.g. MBR , eMBR, SOP, PTP, sampling plans, and work instructions).

- Take part in media fills / Aseptic process simulations.

- Comply with company policies, risk assessments, instructions, and protocols.

- Prepare, review, and revise GMP critical documentation.

- Participate in projects (e.g., internal, and external tech transfer activities, validations, eMBR construction, etc).

- Support periodic calibration, and maintenance and act as a superuser for equipment, instruments, and systems.

- Handling CAPA and initiation of deviation and investigations.

- Supervise and train team members in cleanroom environments and processes.

- Document and monitor quality issues through Procella quality systems.

- Initiate, review and approve change cases.

- Identifying and implementing areas of improvement.

- Ensure GMP compliance by complying with Procellas quality system and relevant guidelines, standards, and regulatory requirements

- Ensure GMP compliance within the development of documentation, revision, and training.

- Ensure GMP compliance within the validation lifecycle of equipment, systems, utilities, and processes.

Required qualifications and competence

Practical experience:

At least 2 years of proven experience of GMP manufacturing. Experience of cell therapy manufacture is an asset.

Education:

BSc or above in life science or equivalent.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

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SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities.