Validation Lead, Procella Therapeutics

Do you want to use your skills within validation at an exciting company within specialised treatment? 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.

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. 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.

You will ensure that the validation and qualification SOP’s follow cGMP and other regulatory requirement. You will also issue/revise validation documentation such as URS, IQ, OQ, PQ, risk assessments, VMP and be responsible for the validation/qualification reports, and issue deviations, CAPA’s and CC’s when required. You will also implement a calibration and preventive maintenance program. 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.

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
• Be able to speak / write Swedish and English fluently
• You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)

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, you will need the ability to handle new situations with ease as well as many different issues at the same time.

Interested?

In this recruitment process, Procella Therapeutics is collaborating with Mpya Sci & Tech.

Please submit your application no later than the 10th of October. Interviews will be scheduled continuously. Questions? Please contact Linnéa Andersson, +4670 888 65 77 or linnea.andersson@mpyascitech.com.

About Procella Therapeutics

Based in Stockholm, Procella Therapeutics is an early stage biotechnology company focused on developing cardiac stem cell technology leveraging research from Harvard University and Karolinska Institutet with the aim of treating heart failure. Procella is collaborating with AstraZeneca to take our first cellular product candidate from pre-clinical stage to first-in-human studies and, if successful in early trials, further development towards commercial manufacture.

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.