DSP Manufacturing Technician

3PBIOVIAN; Noáin; In loco; EUR 30.000 - 46.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation assistance

40+ vacation days (including paid)

Employee benefits club

Descrizione del lavoro

3PBiovian in Navarra, Spain, is seeking a goal-oriented DSP Manufacturing Technician to support production of recombinant proteins and monoclonal antibodies in microorganisms. You will ensure GMP adherence, operate chromatography equipment, and maintain documentation across the DSP scale-up unit.

Ideal candidates will have 1–2 years in GMP environments, experience with Unicorn and ÄKTA, and be fluent in Spanish with English B2.

Competenze

• Advanced GMP/GLP knowledge required.
• Experience with chromatographic methods and scale-up processes.
• Familiarity with GMP documentation and quality systems.

Mansioni

• Prepare, control and develop DSP processes for production of biologics.
• Maintain equipment and facilities in good repair per manufacturer manuals.
• Program chromatography methods in Unicorn to ensure correct DSP execution.
• Participate in audits and transfer of technologies between sites.

Conoscenze

GMP/GLP regulations

Chromatographic operations

Audit readiness

Formazione

Advanced Vocational Training in related areas

University Degree in Biology/Biochemistry/Biotechnology/Chemistry

Master's Degree in related areas (valued)

Strumenti

Unicorn

ÄKTA

Descrizione del lavoro

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 to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Inglés etc.)
• 3PBio is committed to the continuous, updated and personalized improvement of our personnel's learning. To this end, we have Learning & Development department, who is in charge of creating personalized, individualized and differentiating career plans for our employees.
• The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling. We offer opportunities for professional growth and take an environment of trust.
• We encourage the participation of our employees in solidarity events such as charity races, social donations...
• We have several programs aimed at improving the physical, psychological and emotional well-being of our employees. In this context, we participate in the Corporate Challenge, promote healthy lunches and comfortable and safe work spaces.
• We have a high-impact work environment with flat hierarchies and short decision-making processes.
• ...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 GMP 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 and 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.