Senior Qualification

Bacthera 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. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

**CREATE YOUR OWN FUTURE AS**

**Senior Qualification & Validation Expert (f/m/d) 100%**:
As a successful Q&V Engineer you 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. You are responsible for planning, developing and executing Qualifications and Validations for Drug Substance Processes for our facility in Leon and globally. You will report to the global Head of Engineering Quality.

**I bring with me**:

- 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

**My main tasks**:

- Leads assigned Qualifications and Validations and provides guidance to local teams
- Coordinates and communicates with stakeholders to ensure accurate and timely completion
- Creation of protocols and risk assessments for Qualification in accordance with policy and procedures
- Creation of protocols and risk assessments for Verifications & Validation (sterilization, decontamination and process) in accordance with policy and procedures
- Executes / oversees Qualification & Validation tasks
- Provides 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
- Performs periodical assessment of validity of equipment qualification & validation / periodic reviews
- Reviews and analyzes related Deviations, CAPAs and Changes

**My reasons for choosing Bacthera**:

- Innovative and fast-growing start-up company with short decision-making processes
- Flexible working hours (on-site, with possibility of Home Office
- Motivated, agile and multinational team
- Very attractive salary
- Language courses offered
- Interesting and diversified tasks

**This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you.