Senior Csv Expert

hace 1 semana

León, España Bacthera A tiempo completo

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 CSV Expert (f/m/d)
As a successful CSV Engineer you ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities. You are responsible for planning, developing and executing Computer System Validations for 4 Facilities. You will report to the global Head of Engineering Quality.

My main tasks will be…

Developing CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards

Developing of protocols for CSV in accordance with policy and procedures

Leading assigned CSV for the process equipment of 4 facilities and providing guidance to local teams

Leads and supports CSV projects and related activities for IT supported system

Delivery of a complete validation package

User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution

Traceability Matrix, Validation Summary Report, Configurations Specification

Coordinating the cooperation between other system stakeholders (e.g. IT, Suppliers, etc.) including the alignment of Service Level needed

Coordinating/Handling the CSV tasks

Follow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT

Performing the yearly system review for each system

Reviewing and analyzing related Deviations, CAPAs and Changes

Coordinating and communicating with stakeholders to ensure accurate and timely completion

I bring with me…

Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology or related field

A minimum of 5 years of experience in CSV, MES, SCADA and OT systems

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

Independent 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 (Denmark and Switzerland)

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.

Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni. ******

I am looking forward to your application Only direct applications are considered.

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