CSV Engineer

at  CAPGEMINI ENGINEERING

REQUIREMENTS

• Bachelor/Master’s Degree in technical or natural sciences.
• A minimum of 4 years of working experience with CSV.
• A minimum of 3 years of working experience within pharma or a biotech company.
• Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
• Experience on defining strategy and validating computerized manufacturing equipment (CSV context).
• 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.
• Fluent in English.

RESPONSIBILITIES

• Assess and produce the CSV package(s) on an assigned project. Taking accountability for the work to be produced.
• 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.
• 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.
• Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups.
• 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.