MSAT/Validation Specialist

About us

We are a Contract Development and Manufacturing Organization (CDMO) with over 40 biotech companies worldwide that have placed their trust in us. We develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases.

 We are looking for you to be part of our Team!

Your role

We are looking for an MSAT/Validation Specialist to fill a key position reporting directly to the Chief Operations Officer.

It will be your primary responsibility to ensure the integrity and compliance of process validation activities in accordance with GMP regulations and VIVEbiotech internal standards.

Likewise, you will collaborate with the Process Development and Production teams to achieve continuous improvements in our processes, as well as evaluate changes and deviations in the process that may impact compliance with the validation status, designing the necessary actions to ensure maintenance. and correct validation status of the process.

As a subject matter expert (SME), you will provide advice and support to the Upstream (USP), Downstream (DSP) and Fill&Finish (F&F) areas on issues related to manufacturing technology and processes, as well as initiatives and strategies to continually improve their development.

Your responsibilities

• You will collaborate with your direct manager in the development and implementation of process validation projects. You will collaborate in the design of the strategy and in carrying out those defined activities, documenting them in a way that ensures compliance with the GMP criteria in process validation. You will report to your direct manager the outstanding activities and incidents, proposing solutions that affect the continuous improvement of their area.
• You will carry out process validation according to the defined strategy and following the established validation plans. Carrying out Risk Assessment in each of the validation stages, writing the protocols and preparing the corresponding final reports.
• You will coordinate with the different stakeholders the execution of the validation protocols. You will collect the test results, analyze them and edit the corresponding validation report. You will evaluate the incidents and deviations that may appear during validations, ensuring that they are treated in accordance with the Quality System.
• You will review the deviations and change controls associated with the processes, evaluating through the corresponding Risk Assessment their impact on the validation status and proposing those strategies that ensure it.
• You will propose strategies to improve and optimize production processes, for which you must know in depth the production process of VIVEbiotech lentiviral vectors.
• You will be permanently updated regarding new manufacturing and monitoring technologies, equipment and lentivirus manufacturing processes.
• You will ensure that your area of responsibility has ideal working conditions to carry out its activity: personal and human resources, equipment and facilities.
• You will ensure compliance with internal and external dates and milestones.
• You will establish internal links with adjacent departments in the company for the smooth running of projects.
• You will represent the company from a technical point of view in meetings with clients and external presentations on topics related to MSAT Process Validation.
• You will follow those procedures specific to your area and work environment, regarding safety, general quality, and good laboratory and manufacturing practices.
• You will be an example at all times of the VIVE culture: values of behavior and teamwork, customer orientation and continuous improvement in quality, safety and environment.

About you

• University Studies related to Chemistry, Biology, Biotechnology, Biochemistry or similar, with a solid background in Biotechnology, Molecular Biology, Cell Cultures and Bioreactors.
• It is essential to have knowledge of validation of biotech/biological processes as well as experience in very similar functions, within the biotechnology industry, as well as experience in validation of biological processes, in process improvement.
• Excellent IT skills in MS Excel and other MS office tools (Word, PowerPoint).
• You have a high/very high knowledge of English that allows you to maintain both technical and colloquial interlocutions fluently.
• You have a high capacity to manage and work effectively within a team, with leadership.
• You like to work with a positive attitude towards change.
• You have a good resistance to frustration and are good at achieving medium/long-term objectives as a final result of intermediate successes.
• You demonstrate excellent organizational, interpersonal and problem-solving skills.
• You feel comfortable and resilient in an environment of change and able to adjust workload based on changing priorities.
• You are able to work quickly and accurately with a strong focus on details, in a rigorous manner.
• You always focus on high quality (excellence and self-demand) and demonstrate autonomy.
• You are able to work under pressure of results and deadlines, with proactivity and responsibility.

We offer you

• You will have continuous career development that will help you develop your talent throughout your entire professional career.
• You will participate in innovative projects in constant technological update.
• You will have a competitive salary according to your profile for this position.
• You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
• You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
• We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling,…).
• You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
• We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.