GMP Manufacturing Technician
We are a Contract Development and Manufacturing Organization (CDMO) with over 20 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 looking for a talented and highly motivated GMP MANUFACTURING TECHNICIAN, who will fill a key position reporting directly to the Manufacturing Responsible, who will be the guarantor and responsible for compliance with GMP standards in all the Manufacturing department, working on the continuous improvement of the department, providing constant support in changes and managing ideas and records related to deviations, improvements, etc.
We value experience in GMP environments and in the pharmaceutical sector.
- You will be responsible for the investigations associated with the deviations and the corresponding CAPAS.
- You will draft the section SOPs.
- You will elaborate and coordinate the section’s change controls.
- You will manage the calibrations together with the Technical Services Manager, as well as the validations and qualifications of the section.
- You will support customer and agency audits.
- You will know in depth the processes of the section.
- You will coordinate with Quality Assurance to implement new quality policies in the section.
- You will keep up to date the documentation status of the section according to GXP.
- You will receive GMP batch deviations and other batch incidents for investigation.
- Coordinate the implementation of the corresponding CAPAs.
You will draft new SOPs for the section and report changes in SOPs to schedule staff training.
- You will elaborate the section’s change controls and coordinate them internally (if multi-departmental).
- As the most knowledgeable of the section SOPs and GXP level situations you will be present in audits with a relevant role.
- You will liaise with the Quality Assurance area for investigations, layers, claims, change controls, audits, etc.; with the person in charge of production for daily management, incident reporting, new SOPs and CAPAS; with the Quality Control Technicians for incident reporting and with the person in charge of Technical Services and General Plant Services, for new implementations or problems related to equipment.
- You have a university degree, preferably in Pharmacy.
- You have knowledge of cell culture.
- You have knowledge of pharmaceutical manufacturing in GMP environments and you know the GxP regulations.
- You have a level of English that allows you to understand and speak with ease to manage documentation correctly and to be able to participate in work meetings.
- You like to lead and work in a team.
- You are an analytical and organized person, who likes management by objectives.
- You are passionate about continuous learning and you like to solve problems.
- You are a detailed and meticulous person, very responsible and proactive.
- You work in an orderly and structured way.
- You are resilient and flexible when facing changes and under pressure of deadlines and results.
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.