csv engineer in Bern

posted
contact
Moutusi Chattopadhyay, Zurich IT Professionals
job type
contract
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job details

posted
location
bern
sector
engineering
job type
contract
reference number
17466
contact
moutusi chattopadhyay, zurich it professionals
phone
058 201 56 67

job description

 

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
  • 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.
Looking forward to your applications. Good Luck.