Validation Engineer CSV

Major Interfaces 

· Technical Services and all other departments on site which rely on CSV services

Aim of the position 

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

o Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities 

o Validation Master plans are up to date and established for all ongoing projects
 

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, PQ test scripts. · Perform CSV period 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 

· Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV 

· Support Technical Services department KPI. 

· Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures 

· 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 commissioning, and qualification process are assessed and resolved.
 

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 minimal 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 
 

· Basic know-how of Qualification requirements according to cGMP regulations 
 

· Basic know-how of quality assurance principles