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CSV Engineer.

Job Details

zusammenfassung.

  • Branche
    Engineering
  • Kontakt
    Moutusi Chattopadhyay
  • Referenznummer
    17467

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Job Details

     CSV Engineer

 

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


Responsibilities :

  • 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
  • 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 in the TrackWise system is a plus.
  • Experience in validating complex computerized analytical equipment
  • Basic know-how of Qualification requirements according to cGMP regulations
  • Basic know-how of quality assurance principles

Don’t hesitate to apply, Good luck.

     CSV Engineer

 

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


Responsibilities :

  • 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
  • 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 in the TrackWise system is a plus.
  • Experience in validating complex computerized analytical equipment
  • Basic know-how of Qualification requirements according to cGMP regulations
  • Basic know-how of quality assurance principles

Don’t hesitate to apply, Good luck.

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MC

Moutusi Chattopadhyay

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