Clean Room Quality Control Technician

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 at all ATMPs meet the required quality, safety, and efficacy standards before being released.

**Education and qualifications**:
**Required**:

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

**Desired**:

- Fluency in Catalan, Spanish, English.

**Experience and knowledge**:
**Required**:

- Technical and practical knowledge of molecular biology, immunology and microbiological techniques (qPCR, flow cytometry, ELISA, mycoplasma, endotoxin, etc.).
- Experience in cell culture techniques.
- Experience working in quality control laboratories, cell culture laboratories or 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 quality guidelines specific for ATMPs.
- Experience in analytical method validation for the release of clinical-grade ATMPs.
- Experience in T-cell based ATMP such as TIL, PBL, CAR-T and TCR.
- Technical and practical knowledge of tissue manipulation, biotechnological techniques and viral vector handling in controlled conditions (clean rooms or similar environments).
- Experience in aseptic processes as well as aseptic process validations.
- Experience in process development for GMP manufacturing.

**Main responsibilities and duties**:

- Performing analytical and microbiological tests on raw materials, in-process samples, and intermediate and final products to verify compliance with specifications.
- Performing analytical method validation in accordance with GMP standards.
- Manage the inventory control of raw materials, starting materials, intermediates, and finished pharmaceutical products.
- Reviewing and validating test results and documentation of analytical testing to ensure data integrity and regulatory compliance.
- Ensuring proper documentation and traceability of all QC 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 analytical instruments. Ensure the proper use and maintenance of laboratory equipment in accordance with GMP standards.
- 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 process validation in accordance with GMP standards.
- Supporting environmental monitoring of the cleanroom to ensure sterile conditions are maintained.
- Supporting handling and processing biological materials under sterile conditions.

**Competences**:

- _Flexible mindset_
- _Teamplayer_
- _Innovative_
- _Proactive_

**Labour conditions**:

- Full-time position: 40h/week.
- Starting date: immediate.
- Gross annual salary: 25.000-29.000 euros (Remuneration will depend on experience and skills. 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 responsibilities within a stimulating work environment.
- Individual training opportunities.
- Flexible working hours.
- 23 days of holidays + 9 personal days.
- Flexible Remuneration Program (including dining checks, health insurance, transportation and more)
- Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports... among many others.
- Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.

**Deadline to apply: 29-07-2025**
- VHIR embraces Equality and Diversity. As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, function