Clean room Production Technician (VHIO)

Reporting to the Clean Room - Advanced Therapies Medicinal Products (ATMPs) Qualified Person (QP) and the Manufacturing Manager, the mission of the role will be to ensure the accurate and aseptic execution of all manufacturing processes of ATMPs under Good Manufacturing Practice (GMP).

Education and qualifications:

• Higher Vocational Training Diploma, University Degree, Master or equivalent qualification in the scientific or healthcare field.

• Fluency in Catalan, Spanish, English.

Experience and knowledge:

• Technical and practical knowledge of tissue manipulation, biotechnological techniques and viral vector handling.
• Experience in cell culture techniques.
• Experience working in GMP manufacturing in controlled conditions (clean rooms or similar environments).
• Experience with drafting technical documents and protocols. Experience with laboratory equipment.
• Computer skills (Office suite and Internet).

Desired:

• Knowledge of GMP and regulatory guidelines specific for ATMPs.
• Experience in process validation for the manufacture of clinical-grade ATMPs.
• Experience in T-cell based ATMP such as TIL, PBL, CAR-T and TCR.
• Technical and practical knowledge of molecular biology, immunology and microbiological techniques (qPCR, flow cytometry, ELISA, mycoplasma, endotoxin, etc.).
• Experience in analytical method validation for the release of clinical-grade ATMPs.
• Experience in process development for GMP manufacturing.

Main responsibilities and duties:

• Performing aseptic processes as well as aseptic process validations in accordance with GMP standards.
• Conducting environmental monitoring of the cleanroom to ensure sterile conditions are maintained.
• Handling and processing biological materials under sterile conditions.
• Manage the inventory control of raw materials, starting materials, intermediates, and finished pharmaceutical products.
• Reviewing and validating manufacturing processes and documentation to ensure data integrity and regulatory compliance.
• Ensuring proper documentation and traceability of all manufacturing activities as part of the batch release process.
• Documenting each step of the process meticulously to maintain traceability and compliance.
• Preparing and operating equipment in accordance with strict protocols. Participate in the verification/calibration of manufacturing instruments. Ensure the proper use and maintenance of GMP equipment.
• Contributing to the drafting and revision of standard operating procedures (SOPs), always ensuring their implementation and full compliance with GMP regulations.
• Supporting quality assurance activities, such as in-process controls and deviation reporting.
• Identifying and reporting deviations or non-conformities and collaborating with other departments in root cause investigations.
• Supporting analytical testing validation in accordance with GMP standards.
• Supporting analytical and microbiological tests on raw materials, in-process samples, and intermediate and final products to verify compliance with specifications.

Competences:

• Flexible mindset
• Teamplayer
• Innovative
• Proactive

 Labour conditions:

• Full-time position: 40h/week.
• Starting date: immediate.
• Gross annual salary: 25.000-29.000 euros /// (Salary ranges are consistent with our Collective Agreement pay scale).
• Contract: Technical and scientific activities contract linked to the project activities.

What can we offer?

• Incorporation to Vall d’Hebron Research Institute (VHIR), a public sector institution that promotes and develops the biomedical research, innovation and teaching at Vall d'Hebron University Hospital (HUVH), the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
• A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.
• Continuous learning and a wide range of