Plant Technical Services Engineer
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!
As part of our growth plans, we are looking for a Plant Technical Services Engineer to fill this key position, reporting directly to the VIVEbiotech Technical Services Manager.
In your role, you will help us to ensure that VIVEbiotech’s equipment and facilities meet the requirements to develop and manufacture lentiviral vectors according to GMP standards.
- Establish an annual plan of preventive maintenances, calibrations and qualifications of VIVEbiotech equipment and installations.
- Ensure that the annual preventive maintenance, calibration and qualification plan is complied with and write the annual report on compliance with the plan.
- Plan facility and supply maintenance activities in collaboration with the VIVEbiotech Facilities and Maintenance Manager.
- Document and/or ensure that performing personnel document activities related to corrective and preventive maintenance, calibrations and qualifications following GMP guidelines.
- Collaborate in the drafting of procedures, investigations, CAPAs and all work leading to the continuous improvement of the processes of use and maintenance of equipment and facilities together with the Quality Assurance department.
- Comply with PRL procedures affecting facilities and equipment on a continuous basis, reporting any incident affecting the safety of workers and the company itself, to the person in charge of occupational risk prevention and his direct manager.
- Provide support in projects related to the acquisition and implementation of new equipment and changes in facilities and supplies.
- To collaborate in the training of the new incorporations to the technical services team.
- Respect the GMP quality standards during all activities related to maintenance / calibrations and qualifications both in clothing and PPE, as in the manipulations to be developed.
- Attend external personnel entering VIVEbiotech facilities to perform maintenance tasks, calibrations and qualifications of equipment and facilities ensuring that they comply with CAE procedures (Coordination of Business Activities) in coordination with the responsible of PRL of the Company.
- Work jointly with internal and external personnel in the resolution of any type of breakdown or incident of production equipment and auxiliary plant services.
- Collaborate with your direct responsible 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 impacts on 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.
- You have a university degree, preferably in Industrial or Mechanical Engineering, or related to the world of Biotechnology.
- We value at least 2 years of experience related to the functions of the position, but it is not essential.
- We value if you have knowledge or complementary training in Good Manufacturing Practices: EMA and FDA and training in Biotechnological processes but in any case, you will receive internal training.
- We value knowledge of calibration requirements and qualification of laboratory equipment and the biotechnological and pharmaceutical field in GMP facilities.
- You have a minimum B2 level of English.
- You like to work to achieve team objectives and you are proactive, leading the achievement of results and with a cooperative attitude.
- You are customer oriented both internally and externally, reporting incidents and proposing solutions to problems and ideas for improvement.
- You are a high quality oriented person (excellence and self-demanding), organized and tidy.
- You have good oral and written communication skills.
- You are a responsible and rigorous person in what you do, demonstrating a high capacity for work, when there is a high demand for results and dates.
- You like to work with a positive attitude towards change and you are flexible.
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.