Senior Csv Expert
hace 2 meses
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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