CSV Engineer

Job content

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

• 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
  

• 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.
  

• 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 required
• 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