DSP Manufacturing Technician

We are looking for a goal-oriented, proactive, and motivated Downstream Technician to join our Manufacturing Operations Department.

Main Responsibilities:

As a DSP Manufacturing Technician , your responsibilities will include:

• Achieve the objectives set by the Team Leader and the DSP manufacturing manager.
• Prepare, control and develop processes for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.
• Comply with good manufacturing practice (GMP), as well as occupational health and safety standards.
• Maintain equipment and facilities in perfect state of repair, ensuring that they are operated according to the manuals provided by the manufacturer.
• Conduct and/or supervise chromatographic runs, as well as all other manufacturing operations.
• Ensure that the necessary material orders are scheduled in the SAP system to meet the production schedule according to the project and the weekly production plan.
• Carry out the control and supervision, the stock of materials needed to perform the daily activities.
• Prepare, pack, evaluate and unpack chromatography columns, as well as supervise these operations performed by Operators.
• Program chromatography methods in UNICORN to ensure the correct execution of DSP processes.
• Prepare and ensure the correct preparation of solutions required for the performance of manufacturing activities.
• Participate in internal / external audits as required by the Quality Assurance Department.
• Participate in the correct transfer of technologies and resources between companies related to 3P Biopharmaceuticals in collaboration with other departments and your manager.

Documentary responsibilities:

• Perform the incoming documentation of new equipment from the Scaling and Manufacturing DSP area under the supervision of the Team Leader DSP (FAB).
• Ensure the maintenance of up to date technical documentation of the DSP process, as well as all documentation related to assigned tasks.
• Record and manage any quality indicators associated with a scaling and manufacturing process. Participate in the investigation of the same together with the Team Leader DSP (FAB).
• Oversee and write SOPs that correspond to the activities carried out in the Scaling and Manufacturing DSP department.
• Prepare the documentation related to the quality system associated with the DSP Scale-up and Manufacturing plant: Deviations; Change Controls; Action Plans; Corrective, preventive and improvement actions, etc).

Assesment criteria:

Education:

1. Advanced Vocational Training or equivalent in related areas (Biology, Biochemistry, Biotechnology, Chemistry, Health, Clinical Laboratory, etc.).
2. University Degree or equivalent in related areas (Biology; Biochemistry; Biotechnology; Chemistry; IPPA; Chemical Engineering, etc.).
3. Master's Degree in related areas (Biology; Biochemistry; Biotechnology; Chemistry; IPPA, etc.) is valued but not required.

Languages: Fluent in Spanish. Intermediate level of English (Level B2 / First Certificate).

Between 1 and 2 years of experience in/with:

1. GMP/GLP regulations
2. Chromatographic equipment
3. Packed chromatographic columns
4. Experience with ÄKTA
5. Experience with Unicorn

Other requirements:

• Open to work in shifts.
• Office Software Package: User Level.
• Unicorn Software Package: User Level.

Why 3PBiovian?

• A permanent and stable position in a competitive growing company.
• A competitive time off package with 41 paid days of vacation.
• 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.)
• All new hires who reside outside Navarra are provided with a relocation service and/or assistance.
• Company benefits club, which allows 3PBIOVIAN employees t