Arbetsbeskrivning

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.

To our Regenerative Medicines segment, Procella Therapeutics AB, we are now seeking an experienced Validation Specialist.

About The Position

We are looking for an experienced validation engineer who has the ability to lead validation work but also to work hands-on with establishment of validation documentation and execution of validation activities within our GMP manufacturing and QC laboratory.

The primary scope of the role is to take full accountability and independent delivery for all qualification/validation activities required. Including facility, production- and QC equipment, hardware and software.

The validation Specialist is the company’s expert in validation and will represent the company in audits and in meetings with internal and external stakeholders.

This role will work closely with cross functional teams internally (manufacturing, QC, Supply Chain). Reporting to the Head of Manufacturing, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

• Developing and manage validation/qualification/verification life cycle procedure(s) for the company
• Ensure that validation/qualification/verification standard procedure(s) are compliance with GMP and other regulatory requirements
• Review/Issue validation documentation such as URS, IQ, OQ, PQ, risk assessments, VMP and reports
• Handling CAPA and initiation of deviation
• Support cross functional and external activities related to validation
• Issue SOP and training related to validation

• Handle various documentation revisions (including SOPs etc.)

Qualifications

• A high-level education (university degree or similar) within relevant area.
• At least 5-10 years’ experience of validation work within the Pharmaceutical industry (GMP) including equipment validation and validation of computerized systems.
• Good understanding and application of GMP and regulatory requirements.
• Be able to speak / write English fluently.

Personal attributes

You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At SmartCella we welcome, and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

If you are interested in this unique opportunity, please submit your application (including a cover letter) today. We will review applications on an ongoing basis and hope to fill the position as soon as possible.

The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities.