CSV Engineer

 CSV Engineer (focus on CAPAS and quality issues) Aim:In charge of Computer System Validation (CSV) activities for the 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.

Tasks:

• Assess and handle quality issues and corrections or CAPAS associated with the scope of CSV.
• 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, and PQ test scripts.
• 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 systems adhering to regulations and company standards.
• Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
• Ensuring completion of CSV Periodic Review activities and assessment of the required corrective actions.
• 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.
• Contribute to ensuring 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.

Competences:

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 in validating computerized manufacturing equipment (CSV context)
• Experience in validating software & hardware infrastructure (e-g: servers, network, and software services).
• A minimum of 4 years of working experience with CSV
• K-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 in the TrackWise system is a plus.
• Experience in validating complex computerized analytical equipment.
• Basic k-how of Qualification requirements according to cGMP regulations.
• Basic k-how of quality assurance principles.

Looking forward to your applications. od Luck.