USP Manufacturing Technician

hace 2 semanas

Noáin, Navarra, España 3PBIOVIAN A tiempo completo

Are you looking for an opportunity to develop your professional career in a CDMO Manufacturing Operations Department?

The successful candidate will join 3PBiovian as a
USP Manufacturing Technician.

R
esponsibilities:

  • Ensure the timely compliance with the planning of the USP Scale-Up and Manufacturing department previously made by a Team leader.

  • Ensure the correct training of the personnel in charge.

  • Prepare, control and develop processes for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.

  • Participate in internal / external audits as required by the Quality Assurance Department.

  • Comply and ensure compliance with GMP standards within the work team.

  • Record and manage any quality indicators associated with a scale-up and manufacturing process. Participate in the investigation of the same together with the Team Leader USP (FAB).

  • Investigate and propose new methods or process innovations to optimize and improve the work in the area.

  • Ensure proper compliance with regulations and correct completion of current documentation.

  • Participate in the correct transfer of technologies and resources between companies related to 3P Biopharmaceuticals in collaboration with other departments and their manager.

  • Perform the entry documentation of new equipment from the USP Scale-up and Manufacturing area under the supervision of the Team Leader USP (FAB).

  • Supervise the correct completion of the new equipment entry documentation.

  • Supervise the correct training of the personnel in charge, if any.

  • Carry out the distribution and supervision of daily activities.

  • Write and keep updated the documentation associated with the production processes carried out in the USP area.

  • Control / monitoring of orders placed in the USP production area using ERP software.

Assesment criteria:

  • University Degree or equivalent in related areas (Pharmacy; Biology; Biochemistry; Biotechnology; Chemistry; IPPA; Chemical Engineering, cell culture etc.)

  • Desirable but not required Master's degree or equivalent in related fields (Biology; Biochemistry; Biotechnology; Chemistry; Organic Chemistry; IPPA; Chemical Engineering, etc.)

  • Intermediate level of English (Level B2 / First Certificate)

  • Open to work in shifts.

  • Software package: Office. User level.

Between 1 and 2 years of experience in/with:

  • GMP/GLP regulations

  • With bioreactors

  • Cell Cultures

  • Microbiological analysis techniques

  • Upstream production positions

  • Biotechnology / Biopharmaceutical Sector


Why 3PBiovian?

  • A permanent and stable position in a competitive growing company.

  • A competitive time off package with 39 paid days of vacation.

  • Additionally you will have an extra day off on the 26th of December.

  • Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income taxes (childcare, health insurance, academic training etc.)

  • Company benefits club, which allows 3P Biovian employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Inglés etc.)

  • All new hires who reside outside Navarra are provided with a relocation service and/or assistance.

  • ...And so much more


Why us?

We know it takes people with passion and a shared purpose to manufacture advanced medicines.

We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients

From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. We have what it takes to help you improve lives.

It's within us.

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