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About Bacthera Ag
Bacthera Ag is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients.
Job Summary
We are seeking a highly skilled Senior Qualification Expert to join our team. As a successful Q&V Engineer, you will ensure that Qualifications and Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities.
Key Responsibilities
- Plan, develop, and execute Qualifications and Validations for Drug Substance Processes for our facility in Leon and globally.
- Report to the global Head of Engineering Quality.
- Lead assigned Qualifications and Validations and provide guidance to local teams.
- Coordinate and communicate with stakeholders to ensure accurate and timely completion.
- Create protocols and risk assessments for Qualification in accordance with policy and procedures.
- Create protocols and risk assessments for Verifications & Validation (sterilization, decontamination and process) in accordance with policy and procedures.
- Provide expertise on process & equipment capabilities on a wide variety of production equipment for Active Pharmaceutical Ingredient (API) and Drug Product (DP) as well as Media and HVAC Systems.
- Perform periodical assessment of validity of equipment qualification & validation / periodic reviews.
- Review and analyze related Deviations, CAPAs and Changes.
Requirements
- Bachelor or Master's degree in Engineering, Pharmaceutical Technology, Chemistry, Biotechnology or equivalent scientific degree.
- A minimum of 5 years of experience in Qualification and Validation.
- Good understanding of manufacturing processes and related process equipment.
- Extensive experience in a regulated pharmaceutical environment and GMP requirements.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- Structured, focused, and well-organized working attitude.
- Self-dependent way of working and taking ownership of assigned tasks.
- Working knowledge of quality systems and regulatory requirements across multiple health authorities.
- Proficient in Spanish and English.
- Ability to travel occasionally to different sites.
