Validation (Csv)

CSV Engineer

Occupation % 100%

**Major Interfaces**
- Technical Services and all other departments on site which rely on CSV services

**Important**:
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:

- Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Validation Master plans are up to date and established for all ongoing projects

A minimum of 3 days per week of site presence is required.

Due to the nature of the position and the tasks to be performed, it may be required to be more than 3 days per week on site, based on demand. Therefore, living in a regular commutable distance from Bern
- Bumplitz is advisable.

**Essential duties**
- Assess and lead the CSV package(s) on an assigned project.

Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.
- Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, Validation Reports.
- Perform CSV periodic review of equipment and systems.
- Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
- Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
- Coordination and oversight of external subcontractors / software suppliers when required
- Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV
- Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems are assessed and resolved.

**Requirements**:
Competencies Essential
- Bachelor/master's degree in technical or natural sciences
- Ability to work in a fast-changing environment
- A minimum of 3 years of working experience within pharma or a biotech company
- Experience on validating computerized manufacturing equipment (CSV context)
- Experience on validating software & hardware infrastructure (e-g: servers, network and software services).
- A minimum of 4 years of working experience with CSV
- Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Ability to work under mínimal supervision; Assess priorities and work well under pressure in a fast-paced environment
- Ability to effectively work as part of a multidisciplinary, international team
- Business fluency in English Preferred
- German language
- Experience on validating complex computerized analytical equipment (QC Laboratory equipment)
- Basic know-how of Validation requirements according to cGMP regulations
- Basic know-how of quality assurance principles

If you are interested and believe you are a good fit, do not hesitate to contact me directly on: +41 61 282 22 13 (Alba Jansa)