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Production Support Specialist

At BioInvent, we are experts in antibodies and cancer biology and strive for developing first-in-class immuno-modulatory antibodies to treat cancer; treatments that have the potential to considerably improve cancer therapy and the life quality of cancer patients. In our biotech company we are approximately 60 employees and we are covering all parts for drug development, including preclinical research, manufacturing and clinical trials. Together we create the exciting future of BioInvent and we welcome you to be part of it - as Production Support Specialist within our manufacturing team.


Overview

The position will support and assist our production with matters such as e.g. deviation investigations, implementation of changes, CAPA activities, validation activities and improvements of our document flow. Our team is LEANed and the position does require that you can work independently.

 

Key responsibilities

  • Compliance activities within our manufacturing team such as:
    • Deviation investigations
    • Change Controls
    • CAPA activities
  • Provide equipment, system and facility qualification guidance and strategy
  • Equipment validation (DQ/IQ/OQ/PQ), including:
    • Plans
    • Protocols
    • Reports
  • Oversee and follow up on activities such as calibrations, scheduled maintenance and periodic review
  • Attend/present during audits and inspections for compliance and validation activities

 

Requirements

You have at least five years of experience from the pharmaceutical industry with good understanding of production and quality matters. A degree within life science or similar fields.

Knowledge and experience with GMP and Lean. You are proficient in written and spoken English & Swedish. 

The position is office based in Lund.


Skills and Capabilities

We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to drive processes forward. You understand the importance of achieving results, keeping deadlines and ensuring  high quality within your work. You are enthusiastic and enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.

If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position! Application: Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/.  Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2019-07-21. Naturally, all applications will be treated in the strictest of confidence.

BioInvent has a collective agreement and contact persons for the Unions are:

Fredrik Wiberg, Akademikerföreningen tfn: 046-28 68 568

Jenny Nilsson, Unionenklubben, tfn: 046-28 62 536

Apply for this job

Or, know someone who would be a perfect fit? Let them know!

Lund

Sölvegatan 41
223 62 Lund Directions info@bioinvent.com 046-2868550

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