Expert Validation Technician

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!

We are seeking a Expert Validation Technician, reporting to the Head of Quality Assurance – Manufacturing.

Your mission will be to ensure integrity and compliance of validation activities in accordance with GMP regulations and VIVEbiotech internal standards.

You will also collaborate with the Operation team to evaluate process changes and deviations that may impact compliance with validation status, designing the necessary actions to ensure the maintenance and correct validation status.

• You will collaborate in the design of the strategy and implementation of validation projects.
• You will review and approve validations in accordance with the defined strategy and following the established validation plans. You will review and approve protocols, final reports, and the raw data supporting the information contained in them.
• You will coordinate with different departments the execution of validation protocols.
• You will apply Risk Management at each stage of validation.
• You will report to your direct manager and to operations managers on key activities and incidents, proposing solutions that contribute to continuous improvement in validation management.
• Additionally, you will collaborate with operations teams to assess changes and deviations in the process that may impact compliance with the validation status, designing the necessary actions to ensure the maintenance and proper condition of validations.
• You will coordinate the management of incidents and deviations that may arise during validations, ensuring they are addressed and closed in accordance with the Quality System.
• You will review deviations and change controls associated with processes, evaluating their impact on the validation status through the corresponding Risk Assessment and proposing strategies to ensure it.
• You will establish internal links with adjacent departments within the company to ensure the smooth progress of projects.
• Collaborate with your direct manager in the development and implementation of the annual management plan for your area of responsibility always with a vision of continuous improvement cost / effectiveness that affects the improvement of the company.
• Report to your direct responsible the activities and incidents highlighted proposing solutions that affect the continuous improvement of your area.
• Assume a leadership role in promoting the VIVE culture inside and outside the team: values of behavior and teamwork, customer orientation and continuous improvement in quality, safety and environment.

We are looking for someone with:

• Background in Pharmacy, Biotechnology, Biology, Biochemistry, or similar fields, complemented by knowledge of Regulatory Compliance (GMP, etc.).
• Expertise in Process Validation.
• Expertise in Good Manufacturing Practices (GMP) as per EMA and FDA standards.
• Previous experience in the pharmaceutical industry in similar roles, with certification in GMP.
• Experience in pharmaceutical industry in similar roles with certification in GMP Part IV (GMP Guidelines specific to Advanced Therapy Drugs), Annex I Sterile Drug Manufacturing, and experience in regulated environments under FDA requirements.
• Experience in root cause analysis and risk management.
• Experience in the use of computer systems applied to the Pharmaceutical industry.
• You are quality-oriented, with a strong sense of excellence and self-demand, and you work in an organized and methodical way.
• You proactively contribute continuous improvement ideas, offering your knowledge and experience to help achieve your department’s goals.
• You are an effective team player, proactive, and collaborative.
• You are responsible and meticulous in your work, and you’re capable of maintaining high performance when faced with demanding results and deadlines.
• You consistently demonstrate a positive attitude toward change.
• Living in Gipuzkoa, or being willing to relocate to the area, will be positively valued.

• 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.