Production Operator

hace 2 semanas

Madrid, España Orgenesis A tiempo completo

**OVERVIEW**

Job Title: Production Operator

Reports to: Production Manager

Department: Production

Direct Reports: None

Location: Niño Jesús Hospital Madrid. Spain

FLSA Category: Full-Time; Non-Exempt

Compensation/Salary: D.O.E.

**DUTIES/RESPONSIBILITIES**
- Responsible for ensuring the highest level of compliance while working under GMP guidelines.
- Operate in cleanrooms and participate in aseptic activities to ensure and produce a high-quality product.
- Ability to conduct and oversee the performance of environmental monitoring sampling and documentation.
- Continuously performing media fill simulations, as part of ensuring ongoing qualifications and standards.
- Maintain a high level of cleanliness throughout the facility before and after every manufacturing activity..
- Control, operate, and clean all machinery and equipment.
- Identify and report of any deviation or unexpected occurrence; proactively mitigate and take any necessary action.
- Document and file batch records, work instructions, test methods, forms, etc. as instructed and as defined by the Good Documentation Practice procedure.
- Regularly communicate with various teams, including QA, and address any issues as they arise.
- Respect, acknowledge, and maintain the highest levels of safety throughout the working area.

**REQUIREMENTS**
- Bachelor's degree in a scientific discipline or related field is required; an advanced degree (e.g., Master's, Ph.D.) is highly desirable.
- Minimum 2 years in a similar role
- In-depth knowledge of cell cultures, aseptic practice, and GMP environment
- Strong understanding of GMP, GCP, and GLP principles, with a focus on cell and gene therapy product development and manufacturing.
- Excellent problem-solving and decision-making skills, with the ability to navigate complex issues.
- Effective communication and interpersonal skills, with the ability to interact with stakeholders at all levels of the organization.
- Proactive, results-oriented mindset with a demonstrated ability to drive change and deliver high-quality results within established timelines.
- Proficient in Microsoft Office (Excel, Word, PowerPoint)
- Fluency in English and Spanish; additional language skills would be a plus.

**INTERESTED?**

**ABOUT US**

Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platforms, with the ultimate goal of providing life changing treatments at the Point of Care to large numbers of patients at low cost.

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