Industrial IT and Gxp CS Specialist - Switzerland (JO719)

Industrial IT and GxP CS Specialist - Switzerland (JO719)

Zenith Technologies is a world leading provider of products and services to the Life Science industry. We are focused on improving our customers’ performance across the manufacturing enterprise through the application of innovative technologies. Zenith Technologies is embedded in numerous world leading Life Science multinational companies where we continue to deliver superior solutions.

We’re looking for dedicated, innovative and driven talent to join our expanding team.

Job title: Industrial IT and GxP CS Specialist

Reporting to: GxP Computerized Systems Leader

Nature of Position: 12 months

Location of Position: Nyon, Switzerland

Role

· Ensure and demonstrate that the specifications, the commissioning, the installation, the operational and performance qualification of new and modified automation and computerized systems are designed and implemented to produce a product that repeatedly and reproducibly meets critical attributes

· Ensure the reliability of the existing automation and computerized systems and follow their maintenance, upgrade, development and installation.

Main Responsibilities:

· Technical:

o Project management:

§ Automated and computerized systems project management in order to improve the reliability and the productivity of the existing equipment

· URS definition

· Technical solution proposal

· System implementation

§ As an automation expert, participate to projects when automation advices are required

o Support:

§ Automation, Computerized and Vision systems administrator

§ Modification and data backup management according to GMP rules

§ Ensure the second tier support of the automation equipment (including system setting)

§ Provide automation expert support to the support team and to the production team

§ Manage the change control according to rules

o Technology watch:

§ Stay abreast of changing technologies and provide guidance/training to personnel on the impact of those new technologies on regulatory compliance, and the impact on potential areas of new or changing responsibilities, workflows and business processes

§ Improve and develop method related to the automation standardization

o Training:

§ Provide the first training level to the end user and/or support engineers

· CSV:

o Proceed to the validation of the automated and computerized systems according to rules (logic security, backup / restore & archive / retrieve processes, change and deviation management, maintenance, recovery and continuity planning, CSV documentation management)

o Manage computerized systems and automated systems validation projects: definition of the validation strategy, risk assessment and test protocols (Installation Qualification, Operational Qualification and User Acceptance Tests) in accordance with international standards (GAMP5) andrules to ensure their compliance with regulatory requirements (21 CFR Part 11, EU GMP Annex 11)

o Perform the change requests of GxP validated computerized systems. Investigate deviations and define appropriate corrective and preventive actions to avoid reoccurrence

· GMP:

o Enforce and drive GMP standards

o GMP knowledge experience to support the requirements expected by swissmedic European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system

o Ensure local implementation of Quality Modules

o Maintain and approve local SOP related to the activity

o Ensure Change management related to the activity

o Ready for any Internal or External Audit

o Follow VSUM methodology for project execution when IT is related

· HSE:

o Apply and support ISEC and HSE requirements

o Anticipate change consequences on health, security and environment

· Communication:

o Communicate with ease in a multi-disciplinary team and with internal departments

o Continuous Improvement: Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work

o Key interactions:

§ Nyon Plant: all departments, IT, Engineering, Maintenance, Manufacturing, Labs, Quality Control and Quality Assurance

Key Performance Indicators

· Completion of the Site Qualification/Validation Master plan

· Qualification status before release for use

· State and retention of documents

· Quality Audits follow-up

· Key identified projects are delivered on time, on budget and that project stage gates and success criteria are met.

· Recognized as an excellent collaborator and partner by the Process units, IT, Engineering, Maintenance and QA

Requirements

· Degree in Automation, Engineering and/or IT (Bachelor / Dipl. Ing. / M. Sc. / B. Sc.)

· 3 years in Automation and GxP IT Systems as well as project management in Pharmaceutical or other FMCG

· Mastery in Qualification of Equipment and/or Facility and/or Utility

· Mastery on Siemens PLC (S7) and Wonderware software suite

· Mastery on MES systems

· French: fluent (oral and written)

· English: fluent (oral and written)

· MS-Office

· Autocad

*Further details on role available to short listed candidates.

To Apply

Apply by sending your CV referencing job order – JO719 to or call Val Neenan Senior Resource Specialist in confidence +353 21 4370271. You can also link in https://www.linkedin.com/in/valneenan

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