Qualification- and validation lead

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking an ambitious Validation leader to join the growing manufacturing team. If you are interested in this unique opportunity, please submit your application (including a cover letter).

About The Position

We are seeking a highly motivated individual with attention to details to join us as Validation leader. The validation leader will be part of the manufacturing development team and oversee the validation projects within the department. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a Validation leader, you will be devising a validation organisation and be responsible for coordinating the validation activities for GMP manufacturing of ATMPs. This role will work closely with cross functional teams internally (development, manufacturing, QC, CMC and, regulatory). Reporting to the Head of Production, 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
- Implement a calibration and preventive maintenance program


Skills & Qualifications:

- Third level degree in a science/engineering/computer subject as a minimum.
- At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
- Good understanding and application of GMP and regulatory requirements.
- Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.


Qualifications

- You must have experience of working with Validation management (writing, reviewing, and approving related documentation), ideally within the pharmaceutical industry
- Be able to speak / write Swedish and English fluently
- You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
- A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- You have at least 5 years of experience from the pharmaceutical industry, preferably within biopharmaceuticals
- Extensive GMP knowledge and experience


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 Procella 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.